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X-Ray Planning foil
EUDAMEDFDA UDIClass I (EU MDR)
Ref K5300.9011
by ALTATEC GmbH
Identity
- Trade Name
- X-Ray Planning foil EUDAMEDCAMLOG® X-Ray Planning foil FDA UDI
- Generic Name
- Dental implant x-ray template FDA UDI
- Device Name
- X-Ray planning foil EUDAMEDX-Ray Planning foil 1:1.4 CAMLOG® SCREW-LINE FDA UDI
- Model / Reference
- K5300.9011 EUDAMEDFDA UDI
- Description
- X-Ray Planning foil 1:1.4 CAMLOG® SCREW-LINE FDA UDI
Identifiers
- Catalog Number
- K5300.9011 FDA UDI
- Primary DI / UDI-DI
- 04099797018813 EUDAMEDE219K530090111 FDA UDI
- Basic UDI-DI
- 40997970008010000000000H8 EUDAMED
- Secondary DI
- E219K530090111 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant x-ray template 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
X-Ray Planning foil 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 | 40997970008010000000000H8 | 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 59afbc57-0fba-4bd5-a9db-b33d5bc1ce1f 61 fields · synced May 31, 2026
- FDA UDI 72be7abf-6906-4b72-beb2-d952bd29f4d9 35 fields · synced May 30, 2026