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CAMLOG® Fixing screw
EUDAMEDFDA UDIClass I (EU MDR)
Ref J4005.2007
by ALTATEC GmbH
Identity
- Trade Name
- CAMLOG® Fixing screw EUDAMEDScrew for impression post FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- CAMLOG® Screw for impression post EUDAMEDScrew for impression post, closed tray, 0.05`` hex d 5.0/6.0 mm FDA UDI
- Model / Reference
- J4005.2007 EUDAMEDFDA UDI
- Description
- Screw for impression post, closed tray, 0.05`` hex d 5.0/6.0 mm FDA UDI
Identifiers
- Catalog Number
- J4005.2007 FDA UDI
- Primary DI / UDI-DI
- 04099797011852 EUDAMEDE219J400520071 FDA UDI
- Basic UDI-DI
- 40997970008110000000000JD EUDAMED
- Secondary DI
- E219J400520071 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CAMLOG® Fixing screw by ALTATEC GmbH — Class I — 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 | 40997970008110000000000JD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED f32420ea-fb51-46ae-bb88-b382f734c1ab 61 fields · synced Jun 20, 2026
- FDA UDI 7636faf3-ca12-4c6c-b564-26bebe57e16b 35 fields · synced May 30, 2026