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PROGRESSIVE-LINE Dense bone drill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J5078.3809
by ALTATEC GmbH
Identity
- Trade Name
- PROGRESSIVE-LINE Dense bone drill EUDAMEDGuide dense bone drill, PL FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- PROGRESSIVE-LINE Drills EUDAMEDGuide dense bone drill, PL, d 3.8 mm, L 9.0 mm FDA UDI
- Model / Reference
- J5078.3809 EUDAMEDFDA UDI
- Description
- Guide dense bone drill, PL, d 3.8 mm, L 9.0 mm FDA UDI
Identifiers
- Catalog Number
- J5078.3809 FDA UDI
- Primary DI / UDI-DI
- 04099797995985 EUDAMEDE219J507838091 FDA UDI
- Basic UDI-DI
- 40997970004033000000000GR EUDAMED
- Secondary DI
- E219J507838091 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
Dimensions & Sizes
- Size
- Outer Diameter — 3.8 Millimeter FDA UDILength — 9 Millimeter FDA UDI
PROGRESSIVE-LINE Dense bone 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 | 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 81cb2290-07b8-488a-aed7-04e131382e19 61 fields · synced Jul 27, 2026
- FDA UDI 204e609e-d4b6-47ba-9224-b54b6295fff1 36 fields · synced May 30, 2026