Positioner, Tooth, Preformed
Dental · 21 CFR 872.5525
Recent MDR events
1,674 adverse event reports on file
- Byte RetainerJul 27, 2026InjuryStraight Smile Llc3031789024-2026-02834
- Byte RetainerJul 27, 2026InjuryStraight Smile Llc3031789024-2026-02837
- SURESMILE RETAINERJul 22, 2026InjuryDentsply Sirona Orthodontics Inc.1649995-2026-00043
- BYTE RETAINERJul 21, 2026InjuryStraight Smile Llc3031789024-2026-02824
- BYTE RETAINERJul 21, 2026InjuryStraight Smile Llc3031789024-2026-02826
- BYTE RETAINERJul 15, 2026InjuryStraight Smile Llc3031789024-2026-02822
- SURESMILE RETAINERJul 2, 2026InjuryDentsply Sirona Orthodontics Inc.1649995-2026-00035
- SURESMILE RETAINERJun 29, 2026InjuryDentsply Sirona Orthodontics Inc.1649995-2026-00033
- BYTE RETAINERJun 29, 2026InjuryStraight Smile Llc3031789024-2026-02813
- BYTE RETAINERJun 25, 2026InjuryStraight Smile Llc3031789024-2026-02811
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
130 firms currently registered for this product code
Rmo
Franklin, IN, US
Pac-dent Inc.
Brea, CA, US
Pro3dure Medical Gmbh
Iserlohn North Rhine-Westphalia, DE
Jumar Corporation
Bainbridge Is, WA, US
Eptamed Srl
Cesena Forli, IT
Orthometric Ind. E Com. De Prod. Med. Odont.
Marilia Sao Paulo, BR
Keystone Industries
Myerstown, PA, US
Sweetguard Inc
City of Industry, CA, US
Tecnident Equipamentos Ortodonticos Ltda.
SAO CARLOS Sao Paulo, BR
Whip-mix Corp.
LOUISVILLE, KY, US
Scheu-dental Gmbh
ISERLOHN North Rhine-Westphalia, DE
Dentaurum Gmbh & Co. Kg
ISPRINGEN Baden-Wurttemberg, DE
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Prismatik Dentalcraft, Inc.
Irvine, CA, US
Keystone Industries
CHERRY HILL, NJ, US
Myofunctional Research Corp. Pty. Ltd.
HELENSVALE Queensland, AU
Dentsply Sirona Inc
York, PA, US
Hangzhou Wise Medical Device Co.,ltd
Hangzhou Zhejiang, CN
Hantech Medical Device Co., Ltd.
Cixi Zhejiang, CN
Allesee Orthodontic Appliances, Inc.
Sturtevant, WI, US
Sleepcare, Llc
Los Angeles, CA, US
Laboratorios Dentales De Zona Franca, S.a.
CARTAGO, CR
Aspen Surgical Products, Inc.
Caledonia, MI, US
Sharp Detail Orthodontic Laboratory S De El De Cv
Tijuana Baja California, MX
Biotech Dental Smilers, Sas
Salon-de-Provence Bouches-du-Rhone, FR
510(k) clearances
12 clearances for this product code
- ORTHO-TAIN, Inc.Apr 14, 1995
K931615 · NITE-GUIDE
- Dentauraum, Inc.Feb 13, 1995
K942667 · DENT-O-CRYL ORTHODONTIC ACRYLIC
- Glenroe TechnologiesJan 6, 1994
K924351 · GLENROE ELASTIBITE STIMULATOR
- Aquatemp Service Co., Inc.Sep 13, 1993
K925064 · RELAX-O-GUARD
- Myofunctional Research Corp. Pty. , Ltd.Jul 8, 1993
K924975 · THE ORTHOTRAINER
- Myofunctional Research Corp. Pty. , Ltd.Jun 23, 1993
K924974 · THE TMJ APPLIANCE
- American OrthodonticsNov 9, 1990
K904128 · PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
- American OrthodonticsMar 31, 1989
K891328 · PREFORMED TEMPLATE FOR TOOTH POSITIONER