FDA.reportPublic FDA data

Angle Manual Wrench - Intermediate

Primary DI
07901059084993
Brand
Angle Manual Wrench - Intermediate
Company
RP - CONEXOES RESTAURADORAS LTDA
Model
Instrumental
Catalog number
AMWI
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07901059084993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07901059084993079010590849937901059084993

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
898813604
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
079010590848701.3mm Square manual wrench - ShortInstrumental13QMWS2026-04-24
079010590848871.3mm Square manual wrench - IntermediateInstrumental13QMWI2026-04-24
079010590848941.3mm Square manual wrench - LongInstrumental13QMWL2026-04-24
079010590849001.3mm Square manual wrench – Extra LongInstrumental13QMWEL2026-04-24
07901059084917Manual Wrench for Multi-Unit - ShortInstrumentalMWFMS2026-04-24
07901059084924Manual Wrench for Multi-Unit - IntermediateInstrumentalMWFMI2026-04-24
07901059084931Manual Wrench for Multi-Unit - LongInstrumentalMWFML2026-04-24
07901059084948Torx Manual Wrench - ShortInstrumentalTXMWS2026-04-24
07901059084955Torx Manual Wrench - IntermediateInstrumentalTXMWI2026-04-24
07901059084962Torx Manual Wrench - LongInstrumentalTXMWL2026-04-24
07901059084979Torx Manual Wrench – Extra LongInstrumentalTXMWEL2026-04-24
07901059084986Angle Manual Wrench - ShortInstrumentalAMWS2026-04-24
07901059085006Angle Manual Wrench – LongInstrumentalAMWL2026-04-24
07901059085013Unigrip Manual Wrench - ShortInstrumentalUMWS2026-04-24
07901059085020Unigrip Manual Wrench - IntermediateInstrumentalUMWI2026-04-24
07901059085037Unigrip Manual Wrench – LongInstrumentalUMWL2026-04-24
07901059085044Unigrip Manual Wrench – Extra LongInstrumentalUMWEL2026-04-24
079010590850511.28mm Hexagonal Manual Wrench - ShortInstrumental128HMWS2026-04-24
079010590850681.28mm Hexagonal Manual Wrench - IntermediateInstrumental128HMWI2026-04-24
079010590850751.28mm Hexagonal Manual Wrench - LongInstrumental128HMWL2026-04-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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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