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PROGRESSIVE-LINE Profile drill Flex
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J5080.5000
by ALTATEC GmbH
Identity
- Trade Name
- PROGRESSIVE-LINE Profile drill Flex EUDAMEDProfile drill PROGRESSIVE-LINE Flex FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- PROGRESSIVE-LINE Drills EUDAMEDProfile drill PROGRESSIVE-LINE Flex, d 5.0 mm FDA UDI
- Model / Reference
- J5080.5000 EUDAMEDFDA UDI
- Description
- Profile drill PROGRESSIVE-LINE Flex, d 5.0 mm FDA UDI
Identifiers
- Catalog Number
- J5080.5000 FDA UDI
- Primary DI / UDI-DI
- 04099797996197 EUDAMEDE219J508050001 FDA UDI
- Basic UDI-DI
- 40997970004033000000000GR EUDAMED
- Secondary DI
- E219J508050001 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 — 5.0 Millimeter FDA UDI
PROGRESSIVE-LINE Profile drill Flex 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 fd21d075-a71e-400b-b9f8-f4b7b13cfbb8 61 fields · synced May 31, 2026
- FDA UDI fcdc1123-1920-423b-931e-add4f29c15bf 36 fields · synced May 30, 2026