Identity
- Trade Name
- ABUT. PRE MILLED Ø12MM MT16° AG FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- ABUT. PRE MILLED Ø12MM MT16° AG FDA UDI
- Model / Reference
- AFTCM 1601AG FDA UDI
- Description
- ABUT. PRE MILLED Ø12MM MT16° AG FDA UDI
Identifiers
- Catalog Number
- AFTCM 1601AG FDA UDI
- Primary DI / UDI-DI
- 07899995299895 FDA UDI
- 510(k) Number
- K230069 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Abut. Pre Milled Ø12mm Mt16° Ag by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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- Temporary Abutment — Cybermed Inc. · Class II
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Cleared under the same submission
K230069 also covers:
- ABUT. PRE MILLED Ø10MM CM11, 5° DS — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø10MM MT16° DS — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø11, 5MM CM11, 5°MK — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø11, 5MM MT16° MK — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø12MM CM11, 5° AG — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø14MM CM11, 5° DS — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø14MM MT16° DS — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø15, 8MM CM11, 5° MK — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUT. PRE MILLED Ø15, 8MM MT16° MK — S.I.N. - Sistema DE Implante Nacional S.A.
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
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (1)
- FDA UDI 87d5813a-929c-4bca-8265-9feef6f88932 35 fields · synced Jun 8, 2026