Drill, Dental, Intraoral
Dental · 21 CFR 872.4130
Recent MDR events
599 adverse event reports on file
- PROTAPER GOLD ROTARY S2 21MMApr 8, 2026MalfunctionTulsa Dental Products Llc2320721-2026-00032
- GATES RA 28MM 2 *NOT CE*Oct 22, 2025MalfunctionMaillefer Instruments Holding Sarl8031010-2025-00186
- TWIST DRILL STST 2Aug 27, 2025InjuryJjgc S.a.3008261720-2025-003048
- PROTAPER GOLD ROTARY S2 21MMApr 21, 2025MalfunctionTulsa Dental Products Llc2320721-2025-00062
- MINIKINFeb 16, 2024MalfunctionColtene Whaledent Inc.2416455-2024-00002
- MINIKINJan 29, 2024MalfunctionColtene Whaledent Inc.2416455-2024-00001
- DENTAL DRILLFeb 17, 2023InjuryZimmer Dental0002023141-2023-00584
- HALLNov 2, 2022MalfunctionUnk15713799
- PROTAPER SHAPING 2 PTURS225Dec 2, 2021MalfunctionTulsa Dental Products Llc2320721-2021-00106
- PROTAPER SHAPING 1 PTURS121Nov 19, 2021MalfunctionTulsa Dental Products Llc2320721-2021-00103
Event type breakdown
Recalls
3 recall events for this product code
- Straumann USA LLCOpen, ClassifiedMay 28, 2025
Plus Initial Drill, Article Number: 103.170;
The referred batch was produced without the laser engraving of 7 mm.
Z-1861-2025 · View FDA record ↗ - Biomet 3i, LLCTerminatedSep 1, 2009
ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland.
Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.
Z-1947-2009 · View FDA record ↗ - Zimmer Dental IncTerminatedUnknown
THREAD RETRIEVAL DRILL REF 2224
Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Z-3205-2017 · View FDA record ↗
Registered firms
190 firms currently registered for this product code
Ilumi Sciences Inc
Chantilly, VA, US
Chengdu Besmile Medical Technology Co., Ltd.
Chengdu Sichuan, CN
Patterson Dental Supply, Inc.
ST. PAUL, MN, US
Win Wings Corp.
SIALKOT Punjab, PK
Oco Biomedical
ALBUQUERQUE, NM, US
Recherches Techniques Dentaires (r.t.d.)
ST. EGREVE Isere, FR
Reliable Dental Studio, Inc.
Round Rock, TX, US
Warantec Co., Ltd.
Seongnam-si Gyeonggi, KR
D.s.p. Industrial Eireli Epp
Campo Largo Parana, BR
Alliance Global Technology Co., Ltd.
Kaohsiung, TW
Hager & Meisinger Gmbh
NEUSS North Rhine-Westphalia, DE
Arum Dentistry Co., Ltd.
Yuseong-gu Daejeon, KR
Jjgc Industria E Comercio De Materiais Dentarios Sa
Curitiba Parana, BR
Edenta Etablissement
SCHAANWALD Mauren, LI
Shenzhen Dazhou Medical Technology Co., Ltd.
Shenzhen Guangdong, CN
Zonefly Medical Devices Co., Ltd.
Danyang Jiangsu, CN
Toyo Medical Co.
Doral, FL, US
Sentronic International Corp.
Taipei, TW
Rhein 83 Srl
BOLOGNA Emilia-Romagna, IT
Osstem Implant Co., Ltd.
Gangseo-gu Seoul, KR
Dentsply North America Llc
Lancaster, PA, US
Fkg Dentaire Sarl
LE CRET-DU-LOCLE Neuchatel, CH
Brasseler U.s.a. Dental, Llc
SAVANNAH, GA, US
Bio Composants Medicaux (bcm)
SAINT BLAISE DU BUIS Isere, FR
Josef Ganter Feinmechanik Gmbh
DAUCHINGEN Baden-Wurttemberg, DE
510(k) clearances
13 clearances for this product code
- W&H Dentalwerk Buermoos GmbHJun 25, 1999
K984508 · SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
- Del Medical Systems Corp.Sep 25, 1996
K962979 · S-53 INTRORAL DENTAL SYSTEM
- Tulsa Dental Products, Ltd.Jan 16, 1996
K954790 · PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
- Implant Corp. of AmericaJul 27, 1993
K914724 · ADA SHANK EXTENSION
- The Hygenic Corp.Jul 25, 1991
K905418 · GATES GLIDDEN DRILLS
- Ivoclar North America, Inc.Apr 25, 1990
K901097 · FILLOCK REAMER
- Signature One Products, Inc.Jan 19, 1990
K896149 · ANEST-EZE DENTAL DRILL RA#2
- Phillip C. Crawford, D.D.S.Dec 22, 1988
K884187 · INDENTEC DRILL RA #1