FDA product code · Dental
DZEImplant, Endosseous, Root-Form
Product code DZE covers Implant, Endosseous, Root-Form, a Class II device regulated under 21 CFR 872.3640. FDA has cleared 1,547 devices in this code, 27 of them in the last 12 months. Median review time across the 1,547 most recent decisions is 156 days. openFDA lists 210 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3640
- Review panel
- Dental
- Clearances
- 1,547
What is happening in DZE right now?
DZE (Implant, Endosseous, Root-Form) has three findings, most consequential first. 5 first-time filers in the last 12 months, including Inosys, Inc. and Chengdu Besmile Medical Technology Co., Ltd (K260006, K252286, K251605, K251938, K251046). Clearances are running 28% slower — a median 200 days over the last 12 months against 156 days all-time (elapsed calendar days, not FDA review days) (DZE:review_time:12m). The code is crowded, scoring 98 of 100 — 425 companies hold a clearance here and 27 arrived in the last 12 months (DZE:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K260006, K252286, K251605, K251938, K251046 |
| Review time | Context | DZE:review_time:12m |
| Crowding | Context | DZE: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.
How many devices has FDA cleared in DZE?
FDA has cleared 1,547 devices under product code DZE since the 510(k) programme began in 1976, 27 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | |
| K260006 | INOSS System | Inosys, Inc. | |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB |
How long does FDA review take for DZE?
The median FDA review time for DZE is 156 days, measured across the 1,547 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 DZE?
openFDA lists 210 recall records against product code DZE. A recall record covers one firm's corrective action and may span many device lots.
Z-0017-2026Open, ClassifiedS.I.N. Implant System Ltda
Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.
Z-1862-2025Open, ClassifiedStraumann USA, LLC
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Z-1863-2025Open, ClassifiedStraumann USA, LLC
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Z-1101-2025Open, ClassifiedNobel Biocare
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Z-0920-2025Open, ClassifiedSIN SISTEMA DE IMPLANTE NACIONAL S.A
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
Showing the 5 most recently initiated of 210. 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 DZE?
MAUDE holds 1,471,766 adverse-event reports naming product code DZE, 297,306 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 DZE unusual?
One month sits above DZE's own expected range: 1 July 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 38,591 | Insufficient history | No expected range — too little history | |
| 38,173 | Insufficient history | No expected range — too little history | |
| 45,964 | Insufficient history | No expected range — too little history | |
| 41,715 | Insufficient history | No expected range — too little history | |
| 46,809 | Insufficient history | No expected range — too little history | |
| 52,126 | Insufficient history | No expected range — too little history | |
| 43,529 | Insufficient history | No expected range — too little history | |
| 42,447 | Insufficient history | No expected range — too little history | |
| 38,904 | Insufficient history | No expected range — too little history | |
| 46,687 | Insufficient history | No expected range — too little history | |
| 47,610 | Insufficient history | No expected range — too little history | |
| 39,594 | Insufficient history | No expected range — too little history | |
| 32,872 | Insufficient history | No expected range — too little history | |
| 33,425 | Insufficient history | No expected range — too little history | |
| 31,328 | Insufficient history | No expected range — too little history | |
| 35,231 | Insufficient history | No expected range — too little history | |
| 40,084 | Insufficient history | No expected range — too little history | |
| 44,049 | Insufficient history | No expected range — too little history | |
| 45,429 | Insufficient history | No expected range — too little history | |
| 49,595 | Insufficient history | No expected range — too little history | |
| 52,804 | Insufficient history | No expected range — too little history | |
| 40,828 | 29,801–54,556 | Within expected (29,801–54,556) | |
| 32,824 | 26,078–46,732 | Within expected (26,078–46,732) | |
| 35,185 | 29,027–49,857 | Within expected (29,027–49,857) | |
| 16,495 | 28,627–50,080 | Below expected (28,627–50,080) | |
| 11,225 | 15,115–45,780 | Below expected (15,115–45,780) | |
| 21,325 | 4,625–46,594 | Within expected (4,625–46,594) | |
| 93,325 | 3,274–73,129 | Above expected (3,274–73,129) | |
| 44,110 | 9,608–73,281 | Within expected (9,608–73,281) | |
| 38,268 | 11,025–78,063 | Within expected (11,025–78,063) | |
| 37,732 | 9,074–75,632 | Within expected (9,074–75,632) | |
| 38,437 | 7,014–67,030 | Within expected (7,014–67,030) | |
| 42,604 | 9,339–73,698 | Within expected (9,339–73,698) | |
| 38,530 | 12,864–83,449 | Within expected (12,864–83,449) | |
| 41,836 | 8,790–67,694 | Within expected (8,790–67,694) | |
| 37,953 | 11,008–75,149 | Within expected (11,008–75,149) |
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 DZE.
Who has entered DZE in the last year?
5 companies filed in DZE for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Inosys, Inc. | K260006 | |
| Chengdu Besmile Medical Technology Co., Ltd. | K252286 | |
| DIMPLO, Ltd. | K251605 | |
| Paragon Implant Mfg., LLC | K251938 | |
| S.I.N. Implant System Ltda | K251046 |
"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 DZE?
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 DZE?
Across the 1,547 most recent decisions, these applicants filed most often in DZE.
| Applicant | Recent clearances |
|---|---|
| Nobelpharma USA, Inc. | 51 |
| Steri-Oss, Inc. | 40 |
| Implant Innovations, Inc. | 37 |
| Minimatic Implant Technology | 34 |
| Institut Straumann AG | 30 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in DZE files 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 | 31 | 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 DZE
Get an email the morning anything changes in DZE — 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.