FDA.reportPublic FDA data

Elos Accurate® Hybrid Base™ Engaging

Primary DI
05712821000392
Brand
Elos Accurate® Hybrid Base™ Engaging
Company
Elos Medtech Pinol A/S
Model
HBE-NBR43-1
Device description
The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191919000Elos Accurate Hybrid BaseElos Medtech Pinol A/S2020-02-10NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712821000392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821000392057128210003925712821000392

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
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
05712821017123Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017130Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017147Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017161Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017178Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017185Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017192Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
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D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA140Omnibut, Hiossen Regular, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA0Omnibut, MegaGen AnyRidge, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26