FDA.reportPublic FDA data

DIRECT TITANIUM ATTACHMENTS

Primary DI
08059224046945
Brand
DIRECT TITANIUM ATTACHMENTS
Company
RHEIN 83 SRL
Model
OT CAP IMPRESSION COPINGS MICRO SIZE 2 p
Catalog number
044CAIM
Device description
Sterilizable device for the dental impression
Published
2021-07-26
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
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
D821044CAIM0PreviousHIBCC0
08059224046945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224046945080592240469458059224046945

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
Liquid Chemical

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
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
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14