FDA.reportPublic FDA data

Universal Base

Primary DI
05712821007407
Brand
Universal Base
Company
Elos Medtech Pinol A/S
Model
301365
Catalog number
301365
Device description
The Universal Base is a titanium base designed to interface with a dental implant and to support a patient-specific multi-unit direct restoration cemented tothe base. The base and the superstructure form a patient-specific abutment that will support a definitive multi-unit restoration.
Published
2025-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
05712821007407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821007407057128210074075712821007407

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
05712821017758Elos Accurate Pre-Milled BlankPMB-NGM45-1PMB-NGM45-12026-03-06
05712821017369Elos Accurate Pre-Milled BlankPMB-NBR35-1PMB-NBR35-12023-06-19
05712821017376Elos Accurate Pre-Milled BlankPMB-NBR43-1PMB-NBR43-12023-06-19
05712821017383Elos Accurate Pre-Milled BlankPMB-SBO33-1PMB-SBO33-12023-06-19
05712821017390Elos Accurate Pre-Milled BlankPMB-SBO41-1PMB-SBO41-12023-06-19
05712821017406Elos Accurate Pre-Milled BlankPMB-ATE36-1PMB-ATE36-12023-06-19
05712821017413Elos Accurate Pre-Milled BlankPMB-ATE42-1PMB-ATE42-12023-06-19
05712821017420Elos Accurate Pre-Milled BlankPMB-NBR50-1PMB-NBR50-12024-01-04
05712821017437Elos Accurate Pre-Milled BlankPMB-NBR60-1PMB-NBR60-12024-01-04
05712821017444Elos Accurate Pre-Milled BlankPMB-NBA30-1PMB-NBA30-12024-01-04
05712821017451Elos Accurate Pre-Milled BlankPMB-NBA35-1PMB-NBA35-12024-01-16
05712821017468Elos Accurate Pre-Milled BlankPMB-NBA43-1PMB-NBA43-12024-01-16
05712821017475Elos Accurate Pre-Milled BlankPMB-NBA60-1PMB-NBA60-12024-01-04
05712821017482Elos Accurate Pre-Milled BlankPMB-BRA41-1PMB-BRA41-12024-01-04
05712821017499Elos Accurate Pre-Milled BlankPMB-BRA35-1PMB-BRA35-12024-01-04
05712821017505Elos Accurate Pre-Milled BlankPMB-BRA51-1PMB-BRA51-12024-01-04
05712821017512Elos Accurate Pre-Milled BlankPMB-ATO35-1PMB-ATO35-12024-01-04
05712821017529Elos Accurate Pre-Milled BlankPMB-ATO45-1PMB-ATO45-12024-01-04
05712821017536Elos Accurate Pre-Milled BlankPMB-ATE48-1PMB-ATE48-12024-01-04
05712821017543Elos Accurate Pre-Milled BlankPMB-ATE54-1PMB-ATE54-12024-01-04

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