FDA product code · Dental
NHAAbutment, Implant, Dental, Endosseous
Product code NHA covers Abutment, Implant, Dental, Endosseous, a Class II device regulated under 21 CFR 872.3630. FDA has cleared 712 devices in this code, 37 of them in the last 12 months. Median review time across the 712 most recent decisions is 141 days. openFDA lists 224 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3630
- Review panel
- Dental
- Clearances
- 712
What is happening in NHA right now?
NHA (Abutment, Implant, Dental, Endosseous) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1994-2026, Z-1995-2026, Z-1632-2026, Z-1633-2026, Z-0417-2026). 6 first-time filers in the last 12 months, including Sic Invent AG and CreoDent Hudson Valley (K252904, K251515, K253312, K250178, K252266). The code is crowded, scoring 97 of 100 — 155 companies hold a clearance here and 37 arrived in the last 12 months (NHA:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1994-2026, Z-1995-2026, Z-1632-2026, Z-1633-2026, Z-0417-2026 |
| New entrant | Worth knowing | K252904, K251515, K253312, K250178, K252266 |
| Crowding | Context | NHA:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code NHA cover?
NHA is FDA's product code for Abutment, Implant, Dental, Endosseous, a Class II device regulated under 21 CFR 872.3630.
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Source: openFDA device/classification · record NHA · retrieved
How many devices has FDA cleared in NHA?
FDA has cleared 712 devices under product code NHA since the 510(k) programme began in 1976, 37 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG |
How long does FDA review take for NHA?
The median FDA review time for NHA is 141 days, measured across the 712 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in NHA?
openFDA lists 224 recall records against product code NHA. A recall record covers one firm's corrective action and may span many device lots.
Z-1994-2026Open, ClassifiedStraumann USA, LLC
Includes an incorrect screw seat interface.
Z-1995-2026Open, ClassifiedStraumann USA, LLC
Includes an incorrect screw seat interface.
Z-1632-2026Open, ClassifiedStraumann USA, LLC
A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Z-1633-2026Open, ClassifiedStraumann USA, LLC
A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Z-0417-2026Open, ClassifiedPrismatik Dentalcraft, Inc.
Incorrect titanium screw, packaged with dental implant.
Showing the 5 most recently initiated of 224. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for NHA?
MAUDE holds 2,509 adverse-event reports naming product code NHA, 863 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in NHA unusual?
3 months sit above NHA's own expected range: 1 April 2025, 1 October 2025, 1 January 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 68 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 57 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 75 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 52 | Insufficient history | No expected range — too little history | |
| 89 | Insufficient history | No expected range — too little history | |
| 57 | Insufficient history | No expected range — too little history | |
| 85 | Insufficient history | No expected range — too little history | |
| 38 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 74 | Insufficient history | No expected range — too little history | |
| 51 | Insufficient history | No expected range — too little history | |
| 54 | Insufficient history | No expected range — too little history | |
| 42 | Insufficient history | No expected range — too little history | |
| 42 | Insufficient history | No expected range — too little history | |
| 64 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 36 | Insufficient history | No expected range — too little history | |
| 55 | 14–75 | Within expected (14–75) | |
| 34 | 21–61 | Within expected (21–61) | |
| 63 | 21–66 | Within expected (21–66) | |
| 93 | 27–75 | Above expected (27–75) | |
| 45 | 28–92 | Within expected (28–92) | |
| 67 | 26–89 | Within expected (26–89) | |
| 125 | 43–146 | Within expected (43–146) | |
| 46 | 35–121 | Within expected (35–121) | |
| 53 | 27–117 | Within expected (27–117) | |
| 123 | 22–110 | Above expected (22–110) | |
| 31 | 26–124 | Within expected (26–124) | |
| 95 | 10–126 | Within expected (10–126) | |
| 237 | 23–153 | Above expected (23–153) | |
| 151 | 21–204 | Within expected (21–204) | |
| 139 | 32–241 | Within expected (32–241) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in NHA.
Who has entered NHA in the last year?
6 companies filed in NHA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Sic Invent AG | K252904 | |
| CreoDent Hudson Valley | K251515 | |
| Orangecad Med GmbH | K253312 | |
| Adin Dental Implant Systems , Ltd. | K250178 | |
| S.I.N. Implant System Ltda | K252266 | |
| Chengdu Besmile Medical Technology Co., Ltd. | K242768 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in NHA?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in NHA?
Across the 712 most recent decisions, these applicants filed most often in NHA.
| Applicant | Recent clearances |
|---|---|
| Institut Straumann AG | 46 |
| Nobel Biocare AB | 41 |
| Terrats Medical SL | 21 |
| Zimmer Dental, Inc. | 21 |
| Dentsply Sirona | 20 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in NHA file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Institut Straumann AG | 47 | 2 |
| Nobel Biocare | 42 | 2 |
| Straumann USA, LLC | 31 | 2 |
| Dentsply Sirona, Inc. | 23 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch NHA
Get an email the morning anything changes in NHA — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.