TitaniumBase EV ASA (M) 3mm NI 68012580

GUDID 05712821014399

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.

Elos Medtech Pinol A/S

Dental implant suprastructure, permanent, preformed
Primary Device ID05712821014399
NIH Device Record Keyfee12ca1-6222-4724-988e-cf5dfd2a3a36
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitaniumBase EV ASA (M) 3mm NI
Version Model Number68012580
Catalog Number68012580
Company DUNS306155953
Company NameElos Medtech Pinol A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105712821014399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

[05712821014399]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-20
Device Publish Date2024-12-12

Devices Manufactured by Elos Medtech Pinol A/S

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05712821017369 - Elos Accurate Pre-Milled Blank2026-03-09 The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits dire
05712821017376 - Elos Accurate Pre-Milled Blank2026-03-09 The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits dire
05712821017383 - Elos Accurate Pre-Milled Blank2026-03-09 The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits dire
05712821017390 - Elos Accurate Pre-Milled Blank2026-03-09 The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits dire
05712821017406 - Elos Accurate Pre-Milled Blank2026-03-09 The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits dire
05712821017413 - Elos Accurate Pre-Milled Blank2026-03-09 The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits dire
05712821017420 - Elos Accurate Pre-Milled Blank2026-03-09 The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits dire
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