FDA product code · Dental · Class 2
DYH: Adhesive, Bracket And Tooth Conditioner, Resin
DYH is FDA's product code for "Adhesive, Bracket And Tooth Conditioner, Resin": a Class 2 device classified under 21 CFR 872.3750, reviewed by the Dental panel.
510(k) review time for DYH
Across 13 510(k) clearances under DYH decided from 2018-01-01 to 2026-10-06, the median was 108 days from FDA receipt to decision. Half took between 1 and 163 days, and 80% were decided within 180 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 1 |
| Median | 108 |
| 75th percentile | 163 |
| 80th percentile | 180 |
| 90th percentile | 271 |
| Slowest | 323 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
DYH in the public FDA record
| 510(k) clearances, all years | 194 |
|---|---|
| Establishment listings | 233 |
| GUDID device identifiers | 4,350 |
Counts of records, not of devices or events. Adverse event reports for DYH are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite DYH
3 FDA recognized consensus standards cite DYH, among them ISO 29022 First edition 2013-06-01; ISO 7405 Third edition 2018-10 Corrected version 2018-12; ANSI ADA Standard No. 41-2020. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-219 ISO 29022 First edition 2013-06-01 — Dentistry - Adhesive - Notched-edge sheer bond strength test
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-295 ANSI ADA Standard No. 41-2020 — Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.