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CAMLOG® Ball Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref J2249.4315
by ALTATEC GmbH
Identity
- Trade Name
- CAMLOG® Ball Abutment EUDAMEDCAMLOG® Ball abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CAMLOG® Ball abutment, male part EUDAMEDJ2249.4315 CAMLOG® Ball abutment, male part Ø 4.3 mm, GH 1.5 mm FDA UDI
- Model / Reference
- J2249.4315 EUDAMEDFDA UDI
- Description
- J2249.4315 CAMLOG® Ball abutment, male part Ø 4.3 mm, GH 1.5 mm FDA UDI
Identifiers
- Catalog Number
- J2249.4315 FDA UDI
- Primary DI / UDI-DI
- 04099797003598 EUDAMEDE219J224943151 FDA UDI
- Basic UDI-DI
- 40997970001105000000000CY EUDAMED
- Secondary DI
- E219J224943151 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 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
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
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® Ball Abutment by ALTATEC GmbH — Class IIb — 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 | 40997970001105000000000CY | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 00a7833a-4239-4c6e-ad53-4186e6f04dc4 61 fields · synced May 31, 2026
- FDA UDI 588b2a84-11e1-4b6a-8380-7c6552213f66 35 fields · synced May 29, 2026