TitaniumBase EV ASA (XS) 4mm

Primary DI
05712821014122
Brand
TitaniumBase EV ASA (XS) 4mm
Company
Elos Medtech Pinol A/S
Model
68012553
Catalog number
68012553
Device description
The TitaniumBase EV ASA is a two-piece abutment which is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The TitaniumBase EV ASA is available in an indexed variant for single unit restorations and a non-indexed variant for multi-unit restorations. The TitaniumBase EV ASA is available in different gingival heights. The TitaniumBase EV ASA has a chimney height of 7.5 mm which can be shortened as far as 3.5 mm at predefined grooves. TitaniumBase EV ASA size XS is limited to replacement of maxillary lateral incisors and mandibular incisors.
Published
2024-12-12
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
K242025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242025000Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S2024-12-10NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712821014122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821014122057128210141225712821014122

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516873062SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873109SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873345SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873376SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874533SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874564SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874571SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874700SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874717SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874724SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874731SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874748SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874755SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874816SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874847SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516875691SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08