Identity
- Trade Name
- TitaniumBase EV ASA (L) 1mm 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
- 68012562 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
- 68012562 FDA UDI
- Primary DI / UDI-DI
- 05712821014214 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
TitaniumBase EV ASA (L) 1mm by Elos Medtech Pinol A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K242025 also covers:
- TitaniumBase EV ASA (L) 2mm — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (L) 2mm NI — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (L) 3mm — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (M) 1mm NI — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (M) 2mm — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (M) 3mm NI — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (S) 2mm — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (S) 3mm — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (S) 4mm NI — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (XL) 2mm NI — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (XL) 4mm NI — Elos Medtech Pinol A/S
- TitaniumBase EV ASA (XS) 2mm — Elos Medtech Pinol A/S
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 57613c6a-e972-4863-a7ff-c4abb31eac39 35 fields · synced Jun 1, 2026