Plastic Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CILINDER CAST. ABUT. UNIVERSAL Ø3.3X6MM EUDAMEDPlastic Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- PLASTIC ABUTMENT EUDAMEDPLASTIC ABUTMENT SIT Ø3.3X6MM FDA UDI
- Model / Reference
- CCSIT 3360 EUDAMEDFDA UDIPROSTHETIC COMPONENT - NON-STERILE LABORATORY DEVICE PLASTIC ABUTMENT EUDAMED
- Description
- PLASTIC ABUTMENT SIT Ø3.3X6MM FDA UDI
Identifiers
- Catalog Number
- CCSIT 3360 FDA UDI
- Primary DI / UDI-DI
- 07899995205186 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000016JV EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I 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
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
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
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Plastic 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
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 |
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Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 77ab414c-5e7a-458e-a860-dd10898676d3 34 fields · synced Jun 19, 2026
- EUDAMED 7a59a7dd-b409-40a7-ac42-083f19510b36 61 fields · synced Jun 19, 2026