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SCREW-LINE Surgery set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J5065.3809
by ALTATEC GmbH
Identity
- Trade Name
- SCREW-LINE Surgery set EUDAMEDGuide Surgery set, SL FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- CAMLOG® SCREW-LINE Sets and Drills EUDAMEDGuide Surgery set, SL, internal irrigation Ø 3.8 mm L 9.0 mm Ø 3.8 L 9.0 FDA UDI
- Model / Reference
- J5065.3809 EUDAMEDFDA UDI
- Description
- Guide Surgery set, SL, internal irrigation Ø 3.8 mm L 9.0 mm Ø 3.8 L 9.0 FDA UDI
Identifiers
- Catalog Number
- J5065.3809 FDA UDI
- Primary DI / UDI-DI
- 04099797995084 EUDAMEDE219J506538091 FDA UDI
- Basic UDI-DI
- 40997970004007000000000HG EUDAMED
- Secondary DI
- E219J506538091 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
SCREW-LINE Surgery 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 640654c4-a1db-46a3-aeaf-b1d14a420b58 61 fields · synced Jul 25, 2026
- FDA UDI 2f4c8d34-06fe-4a94-8218-0ad39e999035 35 fields · synced May 30, 2026