FDA.reportPublic FDA data

Elos Accurate® Hybrid Base™ Non-Engaging

Primary DI
05712821001283
Brand
Elos Accurate® Hybrid Base™ Non-Engaging
Company
Elos Medtech Pinol A/S
Model
HBN-SSA46-1
Device description
The Hybrid Base coping is intended for dental prosthetic restorations. The Hybrid Base coping is used as an interface between a dental abutment and a zirconia superstructure and will be attached to the abutment using the included prosthetic screw and attached to the zirconia superstructure by cementing.
Published
2020-03-31
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
05712821001283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821001283057128210012835712821001283

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
306155953
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
05712821016225Elos Accurate DigiLoc HousingDLH-DH1-2DLH-DH1-22026-06-26
05712821016232Elos Accurate DigiLoc Retention RingDLR-W-6DLR-W-62026-06-26
05712821017123Elos Accurate DigiLoc AbutmentDLA-ATE36-G2-1DLA-ATE36-G2-12026-06-26
05712821017130Elos Accurate DigiLoc AbutmentDLA-ATE36-G3-1DLA-ATE36-G3-12026-06-26
05712821017147Elos Accurate DigiLoc AbutmentDLA-ATE36-G4-1DLA-ATE36-G4-12026-06-26
05712821017154Elos Accurate DigiLoc AbutmentDLA-ATE42-G2-1DLA-ATE42-G2-12026-06-26
05712821017161Elos Accurate DigiLoc AbutmentDLA-ATE42-G3-1DLA-ATE42-G3-12026-06-26
05712821017178Elos Accurate DigiLoc AbutmentDLA-ATE42-G4-1DLA-ATE42-G4-12026-06-26
05712821017185Elos Accurate DigiLoc AbutmentDLA-SBX45-G2-1DLA-SBX45-G2-12026-06-26
05712821017192Elos Accurate DigiLoc AbutmentDLA-SBX45-G3-1DLA-SBX45-G3-12026-06-26
05712821017208Elos Accurate DigiLoc AbutmentDLA-SBX45-G4-1DLA-SBX45-G4-12026-06-26
05712821017215Elos Accurate DigiLoc AbutmentDLA-NBA35-G2-1DLA-NBA35-G2-12026-06-26
05712821017222Elos Accurate DigiLoc AbutmentDLA-NBA35-G3-1DLA-NBA35-G3-12026-06-26
05712821017239Elos Accurate DigiLoc AbutmentDLA-NBA35-G4-1DLA-NBA35-G4-12026-06-26
05712821017246Elos Accurate DigiLoc AbutmentDLA-NBA43-G2-1DLA-NBA43-G2-12026-06-26
05712821017253Elos Accurate DigiLoc AbutmentDLA-NBA43-G3-1DLA-NBA43-G3-12026-06-26
05712821017260Elos Accurate DigiLoc AbutmentDLA-NBA43-G4-1DLA-NBA43-G4-12026-06-26
05712821017277Elos Accurate DigiLoc AbutmentDLA-NGM45-G2-1DLA-NGM45-G2-12026-06-26
05712821017284Elos Accurate DigiLoc AbutmentDLA-NGM45-G3-1DLA-NGM45-G3-12026-06-26
05712821017291Elos Accurate DigiLoc AbutmentDLA-NGM45-G4-1DLA-NGM45-G4-12026-06-26

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
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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