TitaniumBase EV ASA (S) 4mm NI

FDA UDI

Class II (US FDA UDI)

by Elos Medtech Pinol A/S

Identity

Trade Name: TitaniumBase EV ASA (S) 4mm NI FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 68012577 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 68012577 FDA UDI
Primary DI / UDI-DI: 05712821014368 FDA UDI
510(k) Number: K242025 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental implant suprastructure, permanent, preformed

TitaniumBase EV ASA (S) 4mm NI by Elos Medtech Pinol A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Elos Medtech Pinol A/S

Sources (1)

FDA UDI 6213b1f2-fead-4eb4-bf4a-6d2a86fe37c6 35 fields · synced Jun 1, 2026

TitaniumBase EV ASA (S) 4mm NI

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)