FDA product code · Dental
DYHAdhesive, Bracket And Tooth Conditioner, Resin
Product code DYH covers Adhesive, Bracket And Tooth Conditioner, Resin, a Class II device regulated under 21 CFR 872.3750. FDA has cleared 194 devices in this code, 2 of them in the last 12 months. Median review time across the 194 most recent decisions is 65 days. openFDA lists 1 recall record against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3750
- Review panel
- Dental
- Clearances
- 194
What is happening in DYH right now?
DYH (Adhesive, Bracket And Tooth Conditioner, Resin) has two findings, most consequential first. 1 first-time filer in the last 12 months, Spident Co., Ltd (K261129). The code is crowded, scoring 62 of 100 — 60 companies hold a clearance here and 2 arrived in the last 12 months (DYH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261129 |
| Crowding | Context | DYH: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 DYH?
FDA has cleared 194 devices under product code DYH since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261129 | OrthoFit | Spident Co., Ltd. | |
| K261840 | BracePaste Prime Plus | American Orthodontics | |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | Ormco Corporation | |
| K242537 | BracePaste Fluoride Sealant | American Orthodontics Corp. | |
| K234043 | 3M Transbond Orthodontic Adhesive | 3M Unitek Orthodontic Products | |
| K231817 | AlignerFlow LC | Voco GmbH | |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | |
| K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | |
| K202276 | BracePaste Band and Build LC | American Orthodontics | |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda |
How long does FDA review take for DYH?
The median FDA review time for DYH is 65 days, measured across the 194 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 DYH?
openFDA lists 1 recall record against product code DYH. A recall record covers one firm's corrective action and may span many device lots.
Z-0916-2008TerminatedOrmco Corporation
Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
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 DYH?
MAUDE holds 1 adverse-event reports naming product code DYH, 1 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
Who has entered DYH in the last year?
One company filed in DYH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Spident Co., Ltd. | K261129 |
"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 DYH?
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 DYH?
Across the 194 most recent decisions, these applicants filed most often in DYH.
| Applicant | Recent clearances |
|---|---|
| Reliance Orthodontic Products, Inc. | 23 |
| Sybron Dental Specialties, Inc. | 12 |
| Ormco Corp. | 9 |
| American Orthodontics | 7 |
| Dentsply Intl. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in DYH 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 |
|---|---|---|
| Ormco Corporation | 10 | 2 |
| Pulpdent Corporation | 9 | 2 |
| American Orthodontics Corp. | 8 | 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 DYH
Get an email the morning anything changes in DYH — 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.