Identity
- Trade Name
- Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Standard Straight Abutment FDA UDI
- Model / Reference
- EI-6213 FDA UDI
- Description
- Standard Straight Abutment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290112442642 FDA UDI
- 510(k) Number
- K161743 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Abutment by Etgar - Medical Instruments Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161743 also covers:
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS LTD
- Abutment — ETGAR - MEDICAL INSTRUMENTS 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
- Etgar - Medical Instruments Ltd
Sources (1)
- FDA UDI a0b461a0-7e81-439e-b103-35f5865394f1 34 fields · synced Jun 1, 2026