FDA.reportPublic FDA data

INVASIVE ACCESSORIES AND INSTRUMENTS

Primary DI
08059224160573
Brand
INVASIVE ACCESSORIES AND INSTRUMENTS
Company
RHEIN 83 SRL
Model
MANUAL TORQUE WRENCH
Catalog number
760CRD-US
Device description
Manual reversible torque wrench with UDI marking
Published
2021-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
08059224160573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224160573080592241605738059224160573

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
439240722
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
08059224151496OT EQUATOR-OT BRIDGEANALOGO ACC. da laboratorio EQ144AEY2026-08-27
08059224151502OT EQUATOR-OT BRIDGETRANSFER da IMPRONTA NORMO pz.044CAINY2026-08-27
08059224151519OT EQUATORCAPPETTE EQUATOR NERE da labor140CENY2026-08-27
08059224151526OT EQUATORSMART BOX OT EQUATOR330SBEY2026-08-27
08059224151588OT EQUATORESTRATTORE CAPP. c/st. INSERIT485ICEY2026-08-27
08059224160993OT EQUATORCAPPETTE EQUATOR VIOLA tenuta140CEVY2026-08-27
08059224161006OT EQUATORCAPPETTE EQUATOR ROSA soft pz.140CERY2026-08-27
08059224161013OT EQUATORCONTENITORI ACC. EQUATOR pz.2140CAEY2026-08-27
08059224161037OT EQUATORCAPPETTE EQUATOR B/TRASP. stan140CETY2026-08-27
08059224161044OT EQUATORCAPPETTE EQUATOR GIALLO extra-140CEGY2026-08-27
08059224161051OT EQUATORDISCHETTI PROTETTIVI pz.10100PDY2026-08-27
08059224197746OT EQUATORCAPPETTA ROSA MICRO 6 PZ040CRMSN-SM2026-08-27
08059224197753OT EQUATORCAPPETTA DR8 ARANCIO MICRO, 6 PZ049PCMDR8-SM2026-08-27
08059224197760OT EQUATORCAPPETTA DIAM 2.25, DR8 ROSA040CRNSNDR8-SM2026-08-27
08059224197777OT EQUATORCONTENITORE ACCIAIO MICRO, 2 PZ041CAM-SM2026-08-27
08059224197784OT EQUATORCONTENITORE ACCIAIO NORMO, 2 PZ041CAN-SM2026-08-27
08059224197791OT EQUATORCAPPETTA DIAM 2.50, ROSA040CRNSN-SM2026-08-27
08059224217932OT EQUATOR TITANIUM ABUTMENTALL ON FOUR EASY FIX - ASTRA ø 4 h.1KEF49AS4NC12026-08-27
08059224217949OT EQUATOR TITANIUM ABUTMENTALL ON FOUR EASY FIX SEVEN ø3,3 h.1KEF44SMD3312026-08-27
08059224217956OT EQUATOR TITANIUM ABUTMENTALL ON FOUR EASY FIX YOUSE V 3,3/3,75h.4KEF49NAC3542026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544039808N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-09-18
06009544039815N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-09-18
08800313235302ScanTargetDENTIS CO. ,LTDNDP2026-09-18
08800313235319ScanTargetDENTIS CO. ,LTDNDP2026-09-18
08800313235326MU Gingival ScanBodyDENTIS CO. ,LTDNDP2026-09-18
08800313235425ScanTarget Bite CapDENTIS CO. ,LTDNDP2026-09-18
08800313235432ScanTarget Bite CapDENTIS CO. ,LTDNDP2026-09-18
08059224151496OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151502OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218205OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08800131092064DenQ Sub Multi-unit Pick-up Impression copingDenQ Co.,Ltd.NDP2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
00840481138041LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
00840481138058LOCATOR Angled AbutmentZest Anchors, LLCNDP2026-08-21
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19