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Pilot drill Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J5063.4313
by ALTATEC GmbH
Identity
- Trade Name
- Pilot drill Set EUDAMEDGuide Pilot drill set FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- CAMLOG® SCREW-LINE Sets and Drills EUDAMEDGuide Pilot drill set, Ø 2 mm, internal irrigation Ø 3.8/4.3 mm L 13.0 mm Ø 3.8/4.3 L 13.0 FDA UDI
- Model / Reference
- J5063.4313 EUDAMEDFDA UDI
- Description
- Guide Pilot drill set, Ø 2 mm, internal irrigation Ø 3.8/4.3 mm L 13.0 mm Ø 3.8/4.3 L 13.0 FDA UDI
Identifiers
- Catalog Number
- J5063.4313 FDA UDI
- Primary DI / UDI-DI
- 04099797995053 EUDAMEDE219J506343131 FDA UDI
- Basic UDI-DI
- 40997970004007000000000HG EUDAMED
- Secondary DI
- E219J506343131 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, single-use 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pilot drill Set 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 | 40997970004007000000000HG | 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 25e588d6-8db7-47aa-bbfa-2e8a4ae46d65 61 fields · synced Jul 18, 2026
- FDA UDI 841eac3d-ca44-439d-8fb1-0456d30c7b5e 35 fields · synced May 30, 2026