Explorer, Operative
Dental · 21 CFR 872.4565
Recent MDR events
14 adverse event reports on file
- HU-FRIEDYApr 9, 2026InjuryHu-friedy Mfg. Co., Llc1416605-2026-00003
- PREMIER ROOT CANAL EXPLOREROct 28, 2025InjuryPremier Dental Products Company2511556-2025-00004
- PREMIER CAVITY FINDER¿ EXPLORERMay 2, 2023Injury2511556-2023-00003
- AD SURGICAL NON-STERILE EXPLORERFeb 9, 2021MalfunctionApplied Dental Inc. Dba Ad SurgicalMW5099323
- EXPLORER, OPERATIVEJul 1, 2019InjuryHu-friedy Mfg. Co. Llc1416605-2019-00013
- HU-FRIEDY MFG. CO., LLCMay 11, 2016InjuryHu-friedy Mfg. Co., Llc1416605-2016-00002
- HENRY SCHEINApr 13, 2007OtherShanghai Dental Instrument Factory1416605-2007-00001
- EXPLORER DE #5Dec 22, 2004Shanghai Dental Instrument Factory2411236-2004-13070
- EXPLORER SE #23Dec 1, 2004InjuryShanghai Dental Instrument Factory2411236-2004-12871
- EXPLORER DE #5May 20, 2004InjuryShanghai Dental Instrument Factory2411236-2004-11616
Event type breakdown
Recalls
7 recall events for this product code
- Hu-Friedy Mfg Co, Inc.TerminatedFeb 4, 2005
Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Clas
Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
Z-0526-05 · View FDA record ↗ - Hu-Friedy Mfg Co, Inc.TerminatedFeb 4, 2005
Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Cl
Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
Z-0527-05 · View FDA record ↗ - Hu-Friedy Mfg Co, Inc.TerminatedFeb 4, 2005
Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Cla
Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
Z-0528-05 · View FDA record ↗ - Hu-Friedy Mfg Co, Inc.TerminatedFeb 4, 2005
Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exe
Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
Z-0529-05 · View FDA record ↗ - Hu-Friedy Mfg Co, Inc.TerminatedJul 20, 2004
HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior
Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.
Z-0832-04 · View FDA record ↗ - Hu-Friedy Mfg Co, Inc.TerminatedJul 20, 2004
HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. Made in China. For professional use only. Instruments must be cleaned and sterili
Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.
Z-0833-04 · View FDA record ↗ - Hu-Friedy Mfg Co, Inc.TerminatedJul 20, 2004
HENRY SCHEIN(R) 100-8008 Explorer-Double End #5. Barcode *+H658100800808*. Made in China. For professional use only. Instruments must be cleaned and sterilized
Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.
Z-0834-04 · View FDA record ↗
Registered firms
148 firms currently registered for this product code
Hu-friedy Mfg. Co. Llc
Northbrook, IL, US
Pomee Corporation
Sialkot Punjab, PK
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Biomet Microfixation
Jacksonville, FL, US
Zain's Medical Image
SIALKOT Punjab, PK
Power Dental Usa, Inc.
McHenry, IL, US
Helmut Zepf Medizintechnik Gmbh
SEITINGEN Baden-Wurttemberg, DE
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Applied Dental Inc. Dba Ad Surgical
Sunnyvale, CA, US
E. Hahnenkratt Gmbh
KOENIGSBACH-STEIN Baden-Wurttemberg, DE
Kls Martin Se & Co. Kg
Fridingen Baden-Wurttemberg, DE
Sabri Industries
SIALKOT Punjab, PK
Medisporex (pvt) Ltd.
SIALKOT Punjab, PK
Densol International (private) Limited
Sialkot Punjab, PK
Madina Surgical Works
Sialkot Punjab, PK
Dentalez, Inc., Stardental Division
Lancaster, PA, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Acme Commercial Ways Ltd.
Sialkot Punjab, PK
Dental Studio
Anyang-si Gyeonggi, KR
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Sklar Corporation - Warehouse
Salisbury, MD, US
B. Ali Impex
SIALKOT, Punjab, PK
Oketz Logistics Llc
Coral Gables, FL, US
Shanghai Kangqiao Dental Instruments Factory
SHANGHAI, CN
Shumei Industrial (hebei) Co., Ltd.
Cangzhou Hebei, CN
510(k) clearances
3 clearances for this product code