Identity
- Trade Name
- Spiral Drill EUDAMEDSpiral drill reverse action Re-Set FDA UDI
- Generic Name
- Dental implant extractor FDA UDI
- Device Name
- Spiral drill, reverse action EUDAMEDSpiral drill reverse action for CAMLOG® and CONELOG® Re-Set, Ø 0.82 mm, FDA UDI
- Model / Reference
- J5036.0820 EUDAMEDFDA UDI
- Description
- Spiral drill reverse action for CAMLOG® and CONELOG® Re-Set, Ø 0.82 mm, FDA UDI
Identifiers
- Catalog Number
- J5036.0820 FDA UDI
- Primary DI / UDI-DI
- 04099797994599 EUDAMEDE219J503608201 FDA UDI
- Basic UDI-DI
- 40997970004003000000000DU EUDAMED
- Secondary DI
- E219J503608201 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental implant extractor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Spiral Drill by ALTATEC GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970004003000000000DU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED d415b5eb-6dfd-45de-9f8c-6845a3e2381c 61 fields · synced Jul 16, 2026
- FDA UDI c1533e5c-1fa0-492b-a55f-09e2e2a0a1ea 35 fields · synced May 30, 2026