FDA.reportPublic FDA data

OT EQUATOR-OT BRIDGE

Primary DI
D821130AOA3
Brand
OT EQUATOR-OT BRIDGE
Company
RHEIN 83 SRL
Model
OT EQUATOR ASTRA ACQUA ø 3,5-4 h.3
Catalog number
130AOA3
Published
2020-12-16
Public version status
Update
Distribution status
Not 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
D821130AOA3PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

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
08059224214320OT EQUATORTianium screw Scan Ladder #8VSL82026-05-27
08059224214344OT EQUATORTianium screw Scan Ladder #1VSL12026-05-27
08059224094229OT EQUATOR TITANIUM ABUTMENT OT EQUATOR XIVE TG h.3230XIVTG32026-02-10
08059224115801PLUSPLUS CAP EXTRACTOR-INSERTER488EIP2026-02-10
08059224127798OT EQUATOROT EQUATOR CLEAR CAP #100CN051-1002026-02-10
08059224129044PLUSPINK CAP PLUS #50CN087-502026-02-10
08059224129099PLUSYELLOW CAP PLUS #50CN088-502026-02-10
08059224129143PLUSVIOLET CAP PLUS #50CN089-502026-02-10
08059224133041OT EQUATORPINK PROTECTIVE DISK #100DPR-1002026-02-10
08059224133058OT EQUATORPINK PROTECTIVE DISK #50DPR-502026-02-10
08059224134260OT EQUATORSMART BOX OT EQUATOR #50SBE-502026-02-10
08059224140148OT EQUATORLABORATORY ANALOGS 50 u.AAE-502026-02-10
08059224167497PLUSTransfer Heli-Loc open044CAIP-HE2026-02-10
08059224167503PLUSLaboratory set Standard (with pin)192CPC-HE2026-02-10
08059224167510PLUSLaboratory set Extended (without pin)192CPS-HE2026-02-10
08059224167527OT EQUATORExtraction/insertion tool for caps488EIP-HE2026-02-10
08059224167534PLUSCap without pin yellow (0,6kg / 1,32lbs)140CPG-HE2026-02-10
08059224167541PLUSCap without pin black (lab use)140CPN-HE2026-02-10
08059224167558PLUSCap without pin pink (0,8kg / 1,76lbs)140CPP-HE2026-02-10
08059224167565PLUSCap with pin yellow (0,7kg / 1,54lbs)140CPPG-HE2026-02-10

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
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08