FDA.reportPublic FDA data

OT EQUATOR TITANIUM ABUTMENT

Primary DI
D821OTEQUATOR030IIC3257
Brand
OT EQUATOR TITANIUM ABUTMENT
Company
RHEIN 83 SRL
Model
CERTAIN 3i DIAMETER 3,25 H 7
Device description
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
Published
2016-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D821OTEQUATOR030IIC3257PrimaryHIBCC0

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
Lot or batch
true
Expiration 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
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014894Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014900Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014917Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014924Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014931Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014948Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014955Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014962Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014979Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014986Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06