Identity
- Trade Name
- OneGuide KS Implant Anchor EUDAMEDFDA UDI
- Generic Name
- Dental implantation drilling template stabilization bolt FDA UDI
- Device Name
- Surgical Drill System EUDAMED
- Model / Reference
- OGFAKW EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917109071 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406DRILLH5 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implantation drilling template stabilization bolt FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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 implantation drilling template stabilization bolt
OneGuide KS Implant Anchor by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implantation drilling template stabilization bolt.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (2)
- FDA UDI bc6dab3b-bd58-4607-a7a9-3252516e049c 32 fields · synced Jul 24, 2026
- EUDAMED 0632a5c6-1e62-4b6b-b4d9-b3f56a06f31d 61 fields · synced Jul 24, 2026