Product code DYH: 510(k) clearances and predicates
Product code DYH covers OrthoFit. FDA lists 194 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
194 clearances on file under product code DYH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 so far | 2 |
Recent clearances
Newest DYH clearances in the FDA index, with applicant and decision date:
- K261129, OrthoFit, applicant Spident Co., Ltd., decided 2026-07-02. FDA record
- K261840, BracePaste Prime Plus, applicant American Orthodontics, decided 2026-06-03. FDA record
- K250015, Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive, applicant Ormco Corporation, decided 2025-01-03. FDA record
- K242537, BracePaste Fluoride Sealant, applicant American Orthodontics Corp., decided 2024-08-27. FDA record
- K234043, 3M Transbond Orthodontic Adhesive, applicant 3M Unitek Orthodontic Products, decided 2023-12-22. FDA record
- K231817, AlignerFlow LC, applicant Voco GmbH, decided 2023-12-01. FDA record
- K214054, TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520, applicant Tp Orthodontics, Inc., decided 2022-10-14. FDA record
- K210115, FiteBac CC OrthoSeal, applicant Largent Health, LLC, decided 2021-07-29. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include BracePaste Prime Plus, Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive. Watch new DYH clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DYH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DYH clearances include OrthoFit.
How many 510(k) clearances use product code DYH?
194 at the time this page was generated, from openFDA records.
How do I find a predicate device under DYH?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DYH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.