FDA.report

OT EQUATOR - OT BRIDGE

Primary DI
08059224170312
Brand
OT EQUATOR - OT BRIDGE
Company
RHEIN 83 SRL
Model
Set OT EQUATOR SPLINE ø 3,75-4 +Smartbox h.4
Catalog number
131SPL44
Device description
DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection and the thread are compatible with the specific implant; available in different cuff heights. Retentive caps of different retentive forces, metal housing for the caps and protective disc.
Published
2023-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08059224170312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08059224170312080592241703128059224170312

GMDN Terms

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
Microwave Radiation

Regulatory Flags

DUNS number
439240722
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
08059224167572PLUSCap with pin black (lab use)140CPPN-HE2026-02-10
08059224167589PLUSCap with pin pink (0,9kg / 1,98lbs)140CPPP-HE2026-02-10

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