FDA.reportPublic FDA data

OT EQUATOR

Primary DI
08059224161044
Brand
OT EQUATOR
Company
RHEIN 83 SRL
Model
CAPPETTE EQUATOR GIALLO extra-
Catalog number
140CEGY
Device description
DISPOSABLE devices to be placed into a dental removable prosthesis
Published
2026-08-27
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

Product Codes#

Code, Name table
CodeName
EGGAttachment, Precision, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059224161044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224161044080592241610448059224161044

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
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 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
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
08059224217963OT EQUATOR TITANIUM ABUTMENTOT EQUATOR TiRADIX ø 3,3 h.3030TIR3332026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224151519OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224151526OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224160993OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161006OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161013OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161037OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224161051OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197746OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197753OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197760OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197777OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197784OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224197791OT EQUATORRHEIN 83 SRLEGG2026-08-27
08059224218571PLUSRHEIN 83 SRLEGG2026-08-27
08059224218588PLUSRHEIN 83 SRLEGG2026-08-27
08059224218595PLUSRHEIN 83 SRLEGG2026-08-27
08059224218601PLUSRHEIN 83 SRLEGG2026-08-27
08059224218618PLUSRHEIN 83 SRLEGG2026-08-27
08059224218625PLUSRHEIN 83 SRLEGG2026-08-27
08059224218632PLUSRHEIN 83 SRLEGG2026-08-27
08059224218649PLUSRHEIN 83 SRLEGG2026-08-27
08059224218656PLUSRHEIN 83 SRLEGG2026-08-27
08059224218663PLUSRHEIN 83 SRLEGG2026-08-27
08059224218670PLUSRHEIN 83 SRLEGG2026-08-27
08059224218687PLUSRHEIN 83 SRLEGG2026-08-27
08059224218694PLUSRHEIN 83 SRLEGG2026-08-27
08059224127897OT EQUATORRHEIN 83 SRLEGG2026-06-23
08059224136097OT equatorRHEIN 83 SRLEGG2026-06-23
H0005KX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
H0005TX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08