FDA.reportPublic FDA data

Elos Accurate Hybrid Base H Non-Engaging

Primary DI
05712821007124
Brand
Elos Accurate Hybrid Base H Non-Engaging
Company
Elos Medtech Pinol A/S
Model
HBN-BRA51H-1
Device description
Base is a titanium base designed to interface with a dental implant andto support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support adefinitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate HybridBase Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengagingis intended for multi-unit restorations. Alternatively, a definitive multi-unit restorationmay be cemented directly to the Elos Accurate Hybrid Base.
Published
2021-10-20
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
K201860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201860000Elos Accurate Hybrid BaseElos Medtech Pinol A/S2021-02-19NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712821007124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821007124057128210071245712821007124

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
05712821014696Elos Accurate Hybrid Base G EngagingHBE-ATE30-G1.0HBE-ATE30-G1.02026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingHBE-ATE30-G2.0HBE-ATE30-G2.02026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingHBE-ATE30-G3.0HBE-ATE30-G3.02026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingHBE-ATE30-G4.0HBE-ATE30-G4.02026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingHBE-ATE36-G1.0HBE-ATE36-G1.02026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingHBE-ATE36-G2.0HBE-ATE36-G2.02026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingHBE-ATE36-G3.0HBE-ATE36-G3.02026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingHBE-ATE36-G4.0HBE-ATE36-G4.02026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingHBE-ATE42-G1.0HBE-ATE42-G1.02026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingHBE-ATE42-G2.0HBE-ATE42-G2.02026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingHBE-ATE42-G3.0HBE-ATE42-G3.02026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingHBE-ATE42-G4.0HBE-ATE42-G4.02026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingHBE-ATE48-G1.0HBE-ATE48-G1.02026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingHBE-ATE48-G2.0HBE-ATE48-G2.02026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingHBE-ATE48-G3.0HBE-ATE48-G3.02026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingHBE-ATE48-G4.0HBE-ATE48-G4.02026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingHBE-ATE54-G1.0HBE-ATE54-G1.02026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingHBE-ATE54-G2.0HBE-ATE54-G2.02026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingHBE-ATE54-G3.0HBE-ATE54-G3.02026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingHBE-ATE54-G4.0HBE-ATE54-G4.02026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
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