FDA.reportPublic FDA data

Torque Wrench

Primary DI
06932195327652
Brand
Torque Wrench
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
BSM-BS15-45
Published
2025-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932195327652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932195327652069321953276526932195327652

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial marker (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
554494754
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932195392322BIORES Dental Implant SystemBSM-ZTG37082026-02-28
06932195392339BIORES Dental Implant SystemBSM-ZTG37102026-02-28
06932195392346BIORES Dental Implant SystemBSM-ZTG37122026-02-28
06932195392353BIORES Dental Implant SystemBSM-ZTG37142026-02-28
06932195392360BIORES Dental Implant SystemBSM-ZTG41082026-02-28
06932195392377BIORES Dental Implant SystemBSM-ZTG41102026-02-28
06932195392384BIORES Dental Implant SystemBSM-ZTG41122026-02-28
06932195392391BIORES Dental Implant SystemBSM-ZTG41142026-02-28
06932195392407BIORES Dental Implant SystemBSM-ZTG43082026-02-28
06932195392414BIORES Dental Implant SystemBSM-ZTG43102026-02-28
06932195392421BIORES Dental Implant SystemBSM-ZTG43122026-02-28
06932195392438BIORES Dental Implant SystemBSM-ZTG43142026-02-28
06932195392445BIORES Dental Implant SystemBSM-ZTG48082026-02-28
06932195392452BIORES Dental Implant SystemBSM-ZTG48102026-02-28
06932195392469BIORES Dental Implant SystemBSM-ZTG48122026-02-28
06932195392476BIORES Dental Implant SystemBSM-ZTG48142026-02-28
06932195392483BIORES Dental Implant SystemBSM-ZTG55082026-02-28
06932195392490BIORES Dental Implant SystemBSM-ZTG55102026-02-28
06932195392506BIORES Dental Implant SystemBSM-ZTG55122026-02-28
06932195392513BIORES Dental Implant SystemBSM-ZTG60082026-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
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