Home › Device types › DYJ
Retainer, Screw Expansion, Orthodontic
FDA product code DYJ · Class 1 · Dental
2,109
Registered devices
86
Adverse events
6
Recalls
5
510(k) clearances
Devices with this code
LEONE SPA — LEONE SPALEONE SPA — LEONE SPALEONE SPA — LEONE SPAMolekur T — Shanghai Coherz Technology Co., Ltd.Jones Jig — AMERICAN ORTHODONTICS CORPORATIONORTHOSOURCE — ORTHOSOURCEBowbeer Appliances — Digital Dental Laboratories, IncLEONE SPA — LEONE SPAMiniscope Telescoping Herbst — AMERICAN ORTHODONTICS CORPORATIONLEONE SPA — LEONE SPAN.A. — Forestadent Bernhard Förster GmbHLingual Retainer — Gc Orthodontics America Inc.Masel — Ortho Organizers, Inc.ADITEK — ADITEK DO BRASIL S/AMorelli — Dental Morelli LtdaCLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 25MM - 1UN — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAN.A. — Forestadent Bernhard Förster GmbHN.A. — Forestadent Bernhard Förster GmbHQuick Fix — AMERICAN ORTHODONTICS CORPORATIONLip Bumper — AMERICAN ORTHODONTICS CORPORATIONLEONE SPA — LEONE SPApalex® — DENTAURUM GmbH & Co.KGMiniscope Telescoping Herbst — AMERICAN ORTHODONTICS CORPORATIONLEONE SPA — LEONE SPA
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 |
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