Identity
- Trade Name
- TSIII BA Implant EUDAMEDTS BA Fixture System FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- BA Implant System EUDAMED
- Model / Reference
- BTS3S5010B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209381427 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406BA8J EUDAMED
- 510(k) Number
- K163088 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Czechia 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: Screw endosteal dental implant, two-piece
TS BA Fixture System by OSSTEM IMPLANT Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
- ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
- LW Solid Abutment — Ossvis Co., Ltd. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
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- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
Cleared under the same submission
K163088 also covers:
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
- TS BA Fixture System — OSSTEM IMPLANT Co., Ltd.
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
- OSSTEM IMPLANT Co., Ltd.
Sources (2)
- FDA UDI d96dbcc3-d894-41a7-b7d1-174aac82a5b3 33 fields · synced Oct 8, 2026
- EUDAMED 5f95bcbb-4164-49b5-8a6e-7e470c8b24f0 61 fields · synced Oct 6, 2026