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CAMLOG® Bite registration post
EUDAMEDFDA UDIClass I (EU MDR)
Ref J2141.4300
by ALTATEC GmbH
Identity
- Trade Name
- CAMLOG® Bite registration post EUDAMEDCAMLOG® Bite registration post FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- CAMLOG® Bite registration post, sterile EUDAMEDCAMLOG® Bite registration post, incl. fixing screw and bite registration cap, Ø 4.3 mm, prosthetic height 8.1 mm, titanium alloy/PBT, sterile FDA UDI
- Model / Reference
- J2141.4300 EUDAMEDFDA UDI
- Description
- CAMLOG® Bite registration post, incl. fixing screw and bite registration cap, Ø 4.3 mm, prosthetic height 8.1 mm, titanium alloy/PBT, sterile FDA UDI
Identifiers
- Catalog Number
- J2141.4300 FDA UDI
- Primary DI / UDI-DI
- 04099797010916 EUDAMEDE219J214143001 FDA UDI
- Basic UDI-DI
- 40997970006004000000000HB EUDAMED
- Secondary DI
- E219J214143001 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
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
CAMLOG® Bite registration post 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 | 40997970006004000000000HB | 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 75bba9b9-2708-4c0b-84e2-6e7a570c4e5d 61 fields · synced May 31, 2026
- FDA UDI e9152da5-910d-4ea8-97aa-7e0b9892d6eb 35 fields · synced May 30, 2026