Identity
- Trade Name
- TS Port Angled Abutment EUDAMEDOsstem Abutment System FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Dental Abutment System EUDAMED
- Model / Reference
- TS17PA454RWH EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917072825 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406ABUTMENTRZ EUDAMED
- 510(k) Number
- K182091 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
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Osstem Abutment System by OSSTEM IMPLANT Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
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- EZ Post — Megagen Implant Co. Ltd · Class II
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- MEDENTiKA — Medentika GmbH · Class II
Cleared under the same submission
K182091 also covers:
- ET Multi Ti Base — HIOSSEN INC.
- ET STUD ABUTMENT — HIOSSEN INC.
- ET STUD ABUTMENT — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
- ET Transfer Abutment — HIOSSEN INC.
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
- OSSTEM IMPLANT Co., Ltd.
Sources (2)
- FDA UDI 9ccf0c88-38f9-447f-afe2-e0140773c8f7 34 fields · synced Jun 19, 2026
- EUDAMED 30e2814c-e3a9-46de-8cec-b908fb24a2e4 61 fields · synced Jun 19, 2026