Denture, Plastic, Teeth
Dental · 21 CFR 872.3590
Recent MDR events
56 adverse event reports on file
- RENASYS TOUCH NON CONNECT 4TH ED DEVICEJun 5, 2025MalfunctionSmith & Nephew Medical Ltd.8043484-2025-00059
- DENTURE, PLASTIC, TEETHJun 16, 2020InjuryAspen DentalMW5095040
- BIOFORM IPN PLASTIC TEETH (20° POSTERIORS)Apr 19, 2018InjuryDentsply Prosthetics2585114-2018-00001
- MONDIALSep 25, 2017InjuryKulzer Gmbh3006610834-2017-00001
- MONDIAL 6Oct 30, 2013MalfunctionHeraeus Kulzer Gmbh3006610834-2013-00017
- MONDIAL 6Oct 30, 2013MalfunctionHeraeus Kulzer Gmbh1925223-2013-00155
- MONDIAL 6 (DEVICE 1)Sep 26, 2013MalfunctionHeraeus Kulzer Gmbh3006610834-2013-00015
- MONDIAL 8 (DEVICE 2)Sep 26, 2013MalfunctionHeraeus Kulzer Gmbh3006610834-2013-00016
- MONDIAL 6 (DEVICE 1)Sep 26, 2013MalfunctionHeraeus Kulzer Gmbh1925223-2013-00140
- MONDIAL 8 (DEVICE 2)Sep 26, 2013MalfunctionHeraeus Kulzer Gmbh1925223-2013-00141
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
162 firms currently registered for this product code
Shandong Huge Dental Material Corporation
Rizhao Shandong, CN
Improve Co.,limited
Hong Kong Xinjiang, CN
Bredent Gmbh & Co.kg
SENDEN Bavaria, DE
Ivoclar Vivadent Ag
SCHAAN, LI
Best Value Ceramics Inc
Wyoming, PA, US
Guangzhou Jinguanqiao Industry Co., Ltd
Guangzhou Guangdong, CN
Myerson Llc
Chicago, IL, US
Premium Plus Dental Supplies Inc
BROOKLYN, NY, US
Ivoclar Vivadent Manufacturing Gmbh
NATURNO (BZ) Bolzano, IT
Kulzer Gmbh
HANAU Hesse, DE
Klema Dentalprodukte Gmbh
Meiningen Vorarlberg, AT
Candulor, Ag
Glattpark Zurich, CH
Ivoclar Vivadent Manufacturing, Inc
Somerset, NJ, US
Shenzhen Piocreat 3d Technology Co., Ltd
Shenzhen Guangdong, CN
Ivoclar Vivadent, Inc.
Lipa City Batangas, PH
Vita Zahnfabrik H. Rauter Gmbh & Co. Kg.
BAD SACKINGEN Baden-Wurttemberg, DE
Merz Dental Gmbh
LUETJENBURG Schleswig-Holstein, DE
Wright Health Group
Dundee Dundee City, GB
Shanghai Fanta Dental Materials Co., Ltd.
Shanghai, CN
Masterdent, Ltda
Medellin Antioquia, CO
510(k) clearances
55 clearances for this product code
- Ivoclar Vivadent, Inc.Jan 14, 2014
K132984 · SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
- Wright Health Group , Ltd.Mar 1, 2013
K122955 · DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
- New SteticFeb 12, 2013
K122925 · NEW STETIC ARTIFICIAL TEETH
- Candulor USA, Inc.Dec 6, 2012
K122852 · PHYSIOSTAR NFC
- Shofu Dental CorporationSep 7, 2012
K121749 · VERACIA
- Merz Dental GmbHMay 21, 2012
K120404 · MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
- Ivoclar Vivadent, AGMay 14, 2012
K120736 · SR PHONARES II
- Shofu Dental CorporationFeb 8, 2012
K113426 · VERACIA SA