Alloy, Gold-based Noble Metal
Dental · 21 CFR 872.3060
Recent MDR events
5 adverse event reports on file
- CLEARVISION II, LENS IRRIGATION UNITJan 3, 2017MalfunctionKarl Storz Gmbh & Co. Kg Tuttlingen, Germany9610617-2017-00001
- MINIGOLDNov 1, 2016MalfunctionIvoclar Vivadent, Inc.1316092-2016-00005
- BIOCCLUS KISSApr 30, 2014InjuryDegudent Gmbh9681199-2014-00001
- DEGUDENT UMar 31, 2011InjuryDegudent Gmbh9681199-2011-00001
- REXYLLIUM 5May 19, 2000InjuryJeneric/pentron, Inc.MW1018948
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
59 firms currently registered for this product code
Ivoclar Vivadent, Inc.
AMHERST, NY, US
Crown Trading (hk) Co., Limited
HONG KONG, CN
A.d.l. Dental Lab
Feasterville, PA, US
Shen Fu Arts Lab
Shen Zhen Guangdong, CN
Fseven Dental Technology Zhuhai Co.,ltd
ZHUHAI Guangdong, CN
Global Dental Technologies, Inc.
Rogers, AR, US
World Lab U.s.a.
Irvine, CA, US
Primotec Llc
Norwalk, CT, US
Strategy Milling, Llc
Leetsdale, PA, US
Forbes Dental Prosthetics Inc.
Palanan Makati Central Luzon, PH
Degudent Gmbh
HANAU Hesse, DE
Pan-am Dental, Inc.
Sandy, UT, US
Jensen Industries, Inc.
NORTH HAVEN, CT, US
Smilden Biotechnology Co., Ltd.
New Taipei City, TW
Shenzhen Sunmc Dental Technology Co., Ltd.
Shenzhen Guangdong, CN
Qinhuangdao Audental Metal Technology Co., Ltd.
Qinhuangdao City Hebei, CN
Shenzhen Jiahong Dental Technology Co., Ltd
Shenzhen Guangdong, CN
Ocean Ceramics
Aldergrove British Columbia, CA
Arvit Dental Laboratory Inc.
Southampton, PA, US
Bego Bremer Goldschlaegerei Wilh. Herbst Gmbh & Co. Kg
BREMEN, DE
Digismiles Lab
Philipsburg, PA, US
Aurident, Inc.
FULLERTON, CA, US
510(k) clearances
627 clearances for this product code
- Prometal TechnologiesOct 14, 2005
K052463 · PROMETAL HN86
- Kodent, Inc.Aug 2, 2004
K041378 · BIO 60
- Wieland Dental + Technik GmbH & Co. KGMay 27, 2004
K040672 · PORTA REFLEX
- Wieland Dental + Technik GmbH & Co. KGMay 20, 2004
K040524 · PORTA SOLDER 1090 W
- Heraeus Kulzer, Inc.Mar 3, 2004
K040043 · NDX-40 ALLOY
- Heraeus Kulzer,GmbHMar 1, 2004
K034049 · HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
- Bego U.S.A.Jan 15, 2004
K033279 · GOLD DENTAL CASTING ALLOYS
- We Dong Myung Dental Industrial Co., Ltd.Nov 13, 2003
K033446 · APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82