FDA product code DYH: Adhesive, Bracket And Tooth Conditioner, Resin
DYH is the FDA product code for adhesive, bracket and tooth conditioner, resin. It is a Class II device, regulated under 21 CFR 872.3750 and reviewed by the Dental panel. FDA has cleared 194 510(k) submissions under DYH, 7 in the last five years, from 65 different applicants. The average 510(k) review took 80 days (median 66); 15 days on average over the last three years. FDA has posted 1 recall for DYH devices.
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Bracket And Tooth Conditioner, Resin |
| Device class | Class II |
| Regulation | 21 CFR 872.3750 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DYH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 111 |
| 2019 | 1 | 108 |
| 2020 | 3 | 156 |
| 2021 | 1 | 191 |
| 2022 | 1 | 291 |
| 2023 | 2 | 82 |
| 2024 | 1 | 1 |
| 2025 | 1 | 1 |
| 2026 | 2 | 44 |
Compare with all 510(k) review times · Search every DYH clearance
Top DYH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Reliance Orthodontic Products, Inc. | 23 | 2020-04-27 |
| Sybron Dental Specialties, Inc. | 12 | 2004-11-15 |
| Ormco Corp. | 9 | 2006-07-06 |
| American Orthodontics | 7 | 2026-06-03 |
| Dentsply Intl. | 7 | 2005-04-06 |
60 more applicants have DYH clearances. See the full list in Caduvo.
Most recent DYH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261129 | Spident Co., Ltd. | OrthoFit | 2026-07-02 | 87 |
| K261840 | American Orthodontics | BracePaste Prime Plus | 2026-06-03 | 1 |
| K250015 | Ormco Corporation | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | 2025-01-03 | 1 |
| K242537 | American Orthodontics Corp. | BracePaste Fluoride Sealant | 2024-08-27 | 1 |
| K234043 | 3M Unitek Orthodontic Products | 3M Transbond Orthodontic Adhesive | 2023-12-22 | 1 |
Recalls for DYH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-10-31.
Frequently asked questions
What is FDA product code DYH?
DYH is the FDA product code for adhesive, bracket and tooth conditioner, resin. It is a Class II device, regulated under 21 CFR 872.3750 and reviewed by the Dental panel.
What device class is DYH?
Class II, regulation 21 CFR 872.3750. Typical premarket route: 510(k).
How long does a 510(k) take for product code DYH?
Across 194 cleared submissions the average was 80 days from receipt to decision (median 66).
Which companies have the most DYH clearances?
Reliance Orthodontic Products, Inc. (23); Sybron Dental Specialties, Inc. (12); Ormco Corp. (9); American Orthodontics (7); Dentsply Intl. (7).
Have DYH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DYH
- Run a recall and safety report across every DYH manufacturer
- Watch product code DYH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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