FDA product code · Dental
KLEAgent, Tooth Bonding, Resin
Product code KLE covers Agent, Tooth Bonding, Resin, a Class II device regulated under 21 CFR 872.3200. FDA has cleared 419 devices in this code, 8 of them in the last 12 months. Median review time across the 419 most recent decisions is 70 days. openFDA lists 20 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3200
- Review panel
- Dental
- Clearances
- 419
What is happening in KLE right now?
KLE (Agent, Tooth Bonding, Resin) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Vita Zahnfabrik H. Rauter GmbH & Co. Kg. and Saremco Dental AG (K251587, K252151, K252469). The code is crowded, scoring 85 of 100 — 126 companies hold a clearance here and 8 arrived in the last 12 months (KLE:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K251587, K252151, K252469 |
| Crowding | Context | KLE: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 KLE?
FDA has cleared 419 devices under product code KLE since the 510(k) programme began in 1976, 8 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260485 | Any-Etch | Mediclus Co., Ltd. | |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | |
| K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company | |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | |
| K252151 | els unibond | Saremco Dental AG | |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | |
| K251124 | G-Bond Universal | GC America, Inc. | |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. |
How long does FDA review take for KLE?
The median FDA review time for KLE is 70 days, measured across the 419 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 KLE?
openFDA lists 20 recall records against product code KLE. A recall record covers one firm's corrective action and may span many device lots.
Z-0797-2025Open, Classified3M Unitek Corporation
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Z-1368-2022CompletedUltradent Products, Inc.
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Z-0741-2018TerminatedCosmedent, Inc.
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Z-0955-2017TerminatedVoco GmbH
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
Z-2128-2014TerminatedNovocol, Inc.
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Showing the 5 most recently initiated of 20. 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 KLE?
MAUDE holds 32 adverse-event reports naming product code KLE, 13 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 KLE unusual?
KLE does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
17 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.
Who has entered KLE in the last year?
3 companies filed in KLE for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | K251587 | |
| Saremco Dental AG | K252151 | |
| Dmp Dental Industry S.A. | K252469 |
"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 KLE?
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 KLE?
Across the 419 most recent decisions, these applicants filed most often in KLE.
| Applicant | Recent clearances |
|---|---|
| Dentsply Intl. | 20 |
| Ultradent Products, Inc. | 19 |
| Bisco, Inc. | 18 |
| Heraeus Kulzer, Inc. | 16 |
| Kuraray Medical, Inc. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in KLE 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 |
|---|---|---|
| Heraeus Kulzer, LLC. | 19 | 3 |
| Parkell, Inc. | 16 | 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 KLE
Get an email the morning anything changes in KLE — 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.