Retractor, All Types
Dental · 21 CFR 872.4565
Recent MDR events
34 adverse event reports on file
- OPTIVIEWNov 21, 2025InjurySpofadental A.s.3007743883-2025-00001
- PRONG RETRACTORJan 30, 2025InjuryUnkMW5165459
- RICHARD WOLF SCOPE/INSTRUMENT HOLDERNov 30, 2023MalfunctionRichard Wolf Medical Instruments CorpMW5148635
- OPITVIEW SMALL KITFeb 9, 2021InjuryKerr Hawe Sa8031023-2016-00002
- OPITVIEW SMALL KITFeb 8, 2021InjuryKerr Hawe Sa8031026-2016-00002
- OPTIVIEW SMALL KITFeb 8, 2021InjuryKerr Hawe Sa8031023-2016-00003
- MOUTH PROP - SIL, BL, MEDJul 15, 2020MalfunctionIntegra York, Pa Inc.2523190-2020-00052
- CHARNLEY SHORT RETRACTORDec 10, 2019InjuryUnknownMW5091596
- OPTIVIEWOct 18, 2019InjuryKerr Hawe S.a8031023-2019-00001
- OPTIVIEWOct 18, 2019InjuryKerr Hawe S.a8031023-2019-00002
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
340 firms currently registered for this product code
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Csy International Llc
Rancho Cucamonga, CA, US
Sawbros Industries Pvt Ltd
NOIDA Uttar Pradesh, IN
Hangzhou Wise Medical Device Co.,ltd
Hangzhou Zhejiang, CN
Sino Ortho Limited
HANGZHOU Zhejiang, CN
Plasdent Shanghai Co., Ltd.
Shanghai, CN
Pomee Corporation
Sialkot Punjab, PK
Nr Surgical Company
Sialkot Punjab, PK
Holmed Llc
Attleboro, MA, US
Ych Distripark Sdn Bhd
Prai Pulau Pinang, MY
Weldon Instruments
Sialkot Punjab, PK
Medline Industries, Lp - Laredo
LAREDO, TX, US
First Dental Supplies Llc
Winter Garden, FL, US
Zepf Medical Instruments Gmbh
SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE
Cambrian Medical, Inc.
Cedar City, UT, US
Pak Tools Surgical Instruments
Sialkot Punjab, PK
Surgipros Llc
Palmetto, FL, US
Wenzhou Caretek Medical Device Co., Ltd
Wenzhou Zhejiang, CN
Shalatco (pvt) Ltd
Sialkot Punjab, PK
Sgs Export Intl.
SIALKOT Punjab, PK
Huanghua Promisee Dental Co., Ltd
Huanghua Hebei, CN
Devemed Gmbh
NEUHAUSEN OB ECK Baden-Wurttemberg, DE
Ortho Dental Lab, Llc
Antioch, TN, US
Stone Instruments Co.
SIALKOT Punjab, PK
510(k) clearances
8 clearances for this product code
- Ultradent Products, Inc.Jun 3, 1997
K971284 · OPALDAM
- Downs Surgical , Ltd.Feb 25, 1986
K854711 · FIBRELIGHT ILLUMINATING ORAL RETRACTORS
- Universal Prosthetics, Inc.Sep 26, 1983
K832366 · ZOLLER BURNED LIP CONFORMER
- Pacific Dental Corp.Jul 6, 1982
K821784 · BEACH GINGIVAL RETRACTION INSTR. TYPE B
- Den-Mat Corp.Nov 7, 1977
K771973 · GINGITRACT
- L.D. Caulk Co.Aug 26, 1977
K771399 · LIP & CHEEK RETRACTOR
- Septodont, Inc.Nov 19, 1976
K761024 · RACESTYPTINE RINGS
- Septodont, Inc.Sep 27, 1976
K760657 · RACESTYPTINE CORD