Angled Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ABUT. MINI ANG. CM11.5° 2.5X30° EUDAMEDAngled Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- MINI-ABUTMENT | MICRO MINI-ABUTMENT | ANGLED MINI-ABUTMENTS | CONICAL ABUTMENT | MULTIFUNCTIONAL ABUTMENT | CEMENTED ABUTMENT | ANGLED CEMENTED ABUTMENT | ABUTMENT INTERFACE | ABUTMENT INTERFACE (Prosthetic Intermediate) EUDAMEDABUTMENT MINI ANGLED Ø4,8 X 2,5MM X 30° FDA UDI
- Model / Reference
- MAMA 3025 EUDAMEDFDA UDISTERILE COMPONENTS ABUTMENT EUDAMED
- Description
- ABUTMENT MINI ANGLED Ø4,8 X 2,5MM X 30° FDA UDI
Identifiers
- Catalog Number
- MAMA 3025 FDA UDI
- Primary DI / UDI-DI
- 07899995210456 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000005JQ EUDAMED
- 510(k) Number
- K200992 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Angled Abutment by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K200992 also covers:
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Angled Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI ee4fe455-d2d4-469a-baf8-c940d8d0f07f 35 fields · synced Oct 8, 2026
- EUDAMED df14fa69-e87d-4d17-a548-8430255774d0 61 fields · synced Oct 8, 2026