Home › Device types › DYJ
Retainer, Screw Expansion, Orthodontic
FDA product code DYJ · Class 1 · Dental
2,084
Registered devices
86
Adverse events
6
Recalls
5
510(k) clearances
Devices with this code
ORTHOSOURCE — ORTHOSOURCEVECTOR® Screw — Scheu-Dental GmbHN.A. — DENTAURUM GmbH & Co.KGCantilever Bar Offset — AMERICAN ORTHODONTICS CORPORATIONN.A. — Forestadent Bernhard Förster GmbHLEONE SPA — LEONE SPABondable Lingual Retainer — TP ORTHODONTICS INCLEONE SPA — LEONE SPALEONE SPA — LEONE SPAPalatal Arches — AMERICAN ORTHODONTICS CORPORATIONBondable Lingual Retainer — TP ORTHODONTICS INCLEONE SPA — LEONE SPAN.A. — Forestadent Bernhard Förster GmbHRetainer- Soldered 2 arrow head clasps — Digital Dental Laboratories, IncORTHOCLEAR — DEN-MAT HOLDINGS, LLCpalex® — DENTAURUM GmbH & Co.KGLEONE SPA — LEONE SPAN.A. — DENTAURUM GmbH & Co.KGN.A. — DENTAURUM GmbH & Co.KGMasel — Ortho Organizers, Inc.LEONE SPA — LEONE SPALEONE SPA — LEONE SPAN.A. — DENTAURUM GmbH & Co.KGN.A. — DENTAURUM GmbH & Co.KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, an |
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, an |
| 2022-02-07 | Brius Technologies Inc. | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, an |
| 2014-02-24 | Allesee Orthodontic Appliances | The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. |
| 2013-06-06 | Sybron Dental Specialties | The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, |
| 2009-10-02 | Ormco Corporation | Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.