Reamer, Pulp Canal, Endodontic
Dental · 21 CFR 872.4565
Recent MDR events
37 adverse event reports on file
- K-REAMER M-ACCESS 21MM 008Jul 30, 2026MalfunctionMaillefer Instruments Holding Sarl8031010-2026-00118
- K-REAMER M-ACCESS 25MM 015Jul 14, 2026InjuryMaillefer Instruments Holding Sarl8031010-2026-00107
- K-REAMER M-ACCESS 25MM 030Apr 20, 2026MalfunctionMaillefer Instruments Holding Sarl8031010-2026-00051
- MANI REAMERSJan 15, 2026InjuryMani Hanoi Co.ltd3002692886-2026-00001
- K-REAMER M-ACCESS 21MM 020Jul 9, 2025MalfunctionMaillefer Instruments Holding Sarl8031010-2025-00112
- K-REAMER M-ACCESS 25MM 010Apr 2, 2025InjuryMaillefer Instruments Holding Sarl8031010-2025-00047
- GATES-ENLARGERS C.A.Nov 19, 2024MalfunctionVdw Gmbh9611053-2024-00192
- MANI REAMERSOct 17, 2024InjuryMani Hanoi Co. Ltd3002692886-2024-00002
- K-REAMER M-ACCESS 21MM 020Jul 29, 2024MalfunctionMaillefer Instruments Holding Sarl8031010-2024-00093
- GATES AD 32MM 3May 28, 2024MalfunctionTulsa Dental Products Llc2320721-2024-00035
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
60 firms currently registered for this product code
Dentaurum Gmbh & Co. Kg
ISPRINGEN Baden-Wurttemberg, DE
Anqing Clean Dental Instrument Technology Co.,ltd
Anqing City Anhui, CN
Dentsply North America Llc
Lancaster, PA, US
Sterlab
VALLAURIS Alpes-Maritimes, FR
Shenzhen Superline Technology Co.,ltd
Shenzhen Guangdong, CN
Shanghai Smedent Medical Instrument Co., Ltd
Shanghai, CN
Endoperfection Ltd
Worcester Worcestershire, GB
Dentimed Sao Joao
Sunrise, FL, US
Kazan Medical Instruments Plant
Kazan Tatarstan, RU
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Shanghai Fanta Dental Materials Co., Ltd.
Shanghai, CN
Micro-mega Sa
BESANCON Doubs, FR
Ormex S. De R.l. De C.v.
YUCATAN UMAN, MX
Brasseler U.s.a. Dental, Llc
SAVANNAH, GA, US
Ustomed Instrumente Gmbh & Co. Kg
Tuttlingen Baden-Wurttemberg, DE
Jinyuan Medical Equipment(tianjin)co.,ltd
Tianjin, CN
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Gebr. Brasseler Gmbh & Co. Kg
LEMGO North Rhine-Westphalia, DE
Busch & Co. Gmbh & Co. Kg
ENGELSKIRCHEN North Rhine-Westphalia, DE
Integra Lifesciences Production Corporation
Mansfield, MA, US
Holmed Llc
Attleboro, MA, US
Toyo Medical Co.
Doral, FL, US
Diaswiss S.a.
NYON Vaud, CH
Kerr Italia, S.r.l.
SCAFATI Salerno, IT
Mani, Inc. (head Office)
UTSUNOMIYA Tochigi, JP
510(k) clearances
6 clearances for this product code
- United Dental Mfg., Inc.Dec 28, 1982
K823686 · REAMER TYPE K ENDODONTIC
- Union Broach, Div. Moyco Industries, Inc.Sep 28, 1982
K822620 · ROOT CANAL REAMERS, TYPE K
- Ipco Corp.Feb 19, 1980
K800291 · ENDEX REAMERS PULP CANAL, ENDODONTIC
- Janneck Ent. of TexasApr 20, 1977
K770331 · DIALYSIS, JET SYSTEM
- Ransom and RandolphApr 5, 1977
K770598 · ENDODONTIC INSTRUMENTS, R&R CUTWELL
- Cemco Tool Co., Inc.Mar 1, 1977
K770367 · ROOT CANAL FILES & REAMERS