Identity
- Trade Name
- Stopper Drill FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Stopper Drill EUDAMEDCommon Ø2/ L=11.5 FDA UDI
- Model / Reference
- R2SD2011 EUDAMEDFDA UDIR2DS4809 FDA UDI
- Description
- Common Ø2/ L=11.5 FDA UDI
Identifiers
- Catalog Number
- R2DS4809 FDA UDIR2SD2011 FDA UDI
- Primary DI / UDI-DI
- 08806388230648 EUDAMEDFDA UDI08806388268597 FDA UDI
- Basic UDI-DI
- 880972899144Q5 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Stopper Drill by Megagen Implant Co. Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Megagen Implant Co. Ltd
Sources (3)
- FDA UDI e3a51f47-22e5-4b35-a163-22799dfb8d15 33 fields · synced Sep 30, 2026
- FDA UDI e7ff2b7b-d4b2-423b-bf77-f8893cd9d779 34 fields · synced May 30, 2026
- EUDAMED d9ad96d1-d604-49ae-afac-4e85b63620fc 61 fields · synced Sep 30, 2026