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PROGRESSIVE-LINE Dense bone drill 2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J5081.4307
by ALTATEC GmbH
Identity
- Trade Name
- PROGRESSIVE-LINE Dense bone drill 2 EUDAMEDGuide dense bone drill 2, PL FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- PROGRESSIVE-LINE Drills EUDAMEDGuide dense bone drill 2 PL, Ø 4.3 mm, L 7 mm FDA UDI
- Model / Reference
- J5081.4307 EUDAMEDFDA UDI
- Description
- Guide dense bone drill 2 PL, Ø 4.3 mm, L 7 mm FDA UDI
Identifiers
- Catalog Number
- J5081.4307 FDA UDI
- Primary DI / UDI-DI
- 04099797012538 EUDAMEDE219J508143071 FDA UDI
- Basic UDI-DI
- 40997970004033000000000GR EUDAMED
- Secondary DI
- E219J508143071 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
PROGRESSIVE-LINE Dense bone drill 2 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 | 40997970004033000000000GR | 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 92b5b590-4557-4029-822d-511e504e9bfb 61 fields · synced Jul 27, 2026
- FDA UDI df1d722e-8f67-4845-96b4-25d18c8b2f47 35 fields · synced May 30, 2026