Identity
- Trade Name
- MULTI UNIT AESTHETIC ABUTMENTS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- 18° Angular Multi System - H06 FDA UDI
- Model / Reference
- EMA-1861-M FDA UDI
- Description
- 18° Angular Multi System - H06 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290113356580 FDA UDI
- 510(k) Number
- K120530 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
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Multi Unit Aesthetic Abutments by Dentin Implants Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120530 also covers:
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- AESTHETIC ABUTMENTS — DENTIN IMPLANTS TECHNOLOGIES LTD
- ANATOMIC ABUTMENT — DENTIN IMPLANTS TECHNOLOGIES LTD
- ANATOMIC ABUTMENT — DENTIN IMPLANTS TECHNOLOGIES LTD
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
- Dentin Implants Technologies Ltd
Sources (1)
- FDA UDI 40e81b50-10be-4647-b17e-6b402a07e9ae 34 fields · synced Jun 1, 2026