Identity
- Trade Name
- ABUT. PRE MILLED Ø15,8MM CM11,5° MK FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- ABUT. PRE MILLED Ø15,8MM CM11,5° MK FDA UDI
- Model / Reference
- AFTCM 1102MK FDA UDI
- Description
- ABUT. PRE MILLED Ø15,8MM CM11,5° MK FDA UDI
Identifiers
- Catalog Number
- AFTCM 1102MK FDA UDI
- Primary DI / UDI-DI
- 07899995273048 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 Ø15, 8mm Cm11, 5° Mk by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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 Ø12MM MT16° 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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (1)
- FDA UDI 987e1594-0b4c-4127-a64d-8db2b0e1865f 35 fields · synced May 31, 2026