FDA.reportPublic FDA data

OT EQUATOR-OT BRIDGE

Primary DI
08059224095776
Brand
OT EQUATOR-OT BRIDGE
Company
RHEIN 83 SRL
Model
INSERTION / EXTRACTOR TOOL KIT EQ/ILZ
Catalog number
Z-I-KIT-EQ
Device description
STERILIZABLE device with stainless steel insertion and extraction tip for retentive caps and plastic handle.
Published
2024-10-30
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
EJBHandle, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059224095776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224095776080592240957768059224095776

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
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
08961104622142Strip PlacerMELPEX BEAUTY INSTRUMENTSEJB2026-05-21
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08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01
G149NP380630NPSACME ENTERPRISE.EJB2026-05-01
EZPF26179500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179510HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179550HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179560HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179570HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179580HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179590HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
10371347017721Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
10371347017745Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
08800075626905OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627230OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627247OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627254OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627674OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627681OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627735OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627742OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627759OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03