Gutta-percha
Dental · 21 CFR 872.3850
Recent MDR events
128 adverse event reports on file
- GUTTA PERCHA POINTSJul 22, 2025MalfunctionTulsa Dental Products Llc22564311
- UNK MAILLEFERMay 27, 2025InjuryMaillefer Instruments Holding Sarl8031010-2025-00082
- GUTTA-SMART CONFORM FIT GP CRTG 23GApr 18, 2025InjuryTulsa Dental Products Llc2320721-2025-00061
- GUTTA PERCHA, UNKNOWNMar 28, 2025InjuryIntegra Lifesciences Mansfield3014334038-2025-00044
- GUTTA-PERCHAMar 4, 2025InjuryMeta Biomed Co., Ltd.MW5167258
- RECIPROC BLUE GUTTA-PERCHA POINTS - ASSORTMENT - BOX OF 60Jan 27, 2025InjuryVdw Gmbh9611053-2025-00008
- UNK MAILLEFERJan 5, 2022MalfunctionMaillefer Instruments Holding Sarl8031010-2022-00410
- THERMAPREP2 OVENMay 26, 2021Malfunction8031010-2021-00092
- GUTTAFUSION OBTURATOR OVENOct 5, 2018MalfunctionDentsply Vdw Gmbh9611053-2018-00149
- SYBRONENDOJun 13, 2018InjurySybronendo2016150-2018-00020
Event type breakdown
Recalls
3 recall events for this product code
- Ormco CorporationTerminatedNov 4, 2011
Microseal Master Cone Part Number: 815-9033
The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
Z-0160-2012 · View FDA record ↗ - SybronendoTerminatedDec 9, 2009
Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart
Z-0488-2010 · View FDA record ↗ - Ormco/SybronendoTerminatedUnknown
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541
Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.
Z-1083-2016 · View FDA record ↗
Registered firms
109 firms currently registered for this product code
Produits Dentaires Sa
VEVEY (SUISSE) Vaud, CH
Guilin Kevin Peter Technology Co., Ltd.
Guilin Guangxi, CN
Shenzhen Superline Technology Co.,ltd
Shenzhen Guangdong, CN
Tianjin Diadent Co., Ltd.
TIANJIN CITY, CN
Hubei Guarddent Medical Technology Co.,ltd
Wuhan Hubei, CN
Orikam Healthcare India Private Limited
Gurgaon Haryana, IN
Hantech Medical Device Co., Ltd.
Cixi Zhejiang, CN
Maillefer Instruments Holding Sarl
BALLAIGUES Vaud, CH
Xlent Global Inc
Las Vegas, NV, US
Meta Dental Corp.
Glendale, NY, US
Diadent Group Intl., Inc.
Vancouver British Columbia, CA
Symmetry Surgical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Shanghai Xing Yu Medical Equipment Co., Ltd.
SHANGHAI, CN
United Dental Changzhou
Changzhou Jiangsu, CN
Henan Baistra Medical Devices Limited
Zhengzhou Henan, CN
Guilin Yikeshi Medical Device Co Ltd
Guilin Guangxi, CN
Xiantao S&j Protective Products Co., Ltd
Xiantao Hubei, CN
Ormco Corporation
Brea, CA, US
Unitron Group Bv
IJzendijke Zeeland, NL
Ready Set Import
Beverly Hills, CA, US
Anqing Clean Dental Instrument Technology Co.,ltd
Anqing City Anhui, CN
Shanghai Smedent Medical Instrument Co., Ltd
Shanghai, CN
Viarden Lab Llc
Mission, TX, US
Hsg-s Corp
Savannah, GA, US
Denjoy Dental Co., Ltd
Changsha city Hunan, CN
510(k) clearances
23 clearances for this product code
- Hu-Friedy Mfg. Co., Inc.Feb 27, 2008
K073369 · EI DOWNPAK BARRIER SLEEVES
- Endo Twinn B.V.Feb 16, 2007
K070246 · DOWN PAK
- Dr. Howard Martin, P.A.Jun 26, 2006
K051573 · TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
- Endo Twinn B.V.Jan 11, 2005
K042870 · ENDO TWINN
- Pentron Clinical TechnologiesMar 26, 2003
K023819 · FIBERFILL SGP
- Dr. Howard Martin, P.A.Jul 21, 1997
K971641 · ANTIBACTERIAL GUTTA PERCHA
- Tulsa Dental Products, Ltd.Mar 21, 1997
K970134 · THERMAPREP PLUS OVEN
- Union Broach, Div. Moyco Industries, Inc.May 27, 1993
K931742 · INJECT-R FILL