Screw Removal Drill
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Screw Removal Drill EUDAMEDFDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Surgical Drill System (Single use) EUDAMED
- Model / Reference
- TSRD08S EUDAMEDTSRD10L EUDAMEDTSRD08L EUDAMEDHSRD09L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800342270602 EUDAMED08800342270619 EUDAMED08800342270596 EUDAMED08800209372500 FDA UDI
- Basic UDI-DI
- 88000406DRILL1EU EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
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: Fixture/appliance dental drill bit, single-use
Screw Removal Drill 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 Fixture/appliance dental drill bit, single-use.
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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 (4)
- FDA UDI fe4d3d99-a519-4345-af2e-2cf865e56bd8 32 fields · synced Jul 12, 2026
- EUDAMED 132df323-a4d9-4bbc-8953-25f4f1c1ff9f 61 fields · synced Jul 11, 2026
- EUDAMED 7d191a8f-42a8-4f57-8c11-2efc39c2f2b6 61 fields · synced Jul 11, 2026
- EUDAMED 8c9caa3d-37d2-430c-b02c-da0944291165 61 fields · synced Jul 12, 2026