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X-Ray Planning foil
EUDAMEDFDA UDIClass I (EU MDR)
Ref C5300.9015
by ALTATEC GmbH
Identity
- Trade Name
- X-Ray Planning foil EUDAMEDX-Ray planning foil, CONELOG® PROGRESSIVE-LINE Implants FDA UDI
- Generic Name
- Dental implant x-ray template FDA UDI
- Device Name
- X-Ray planning foil EUDAMEDX-Ray planning foil 1.4:1, CONELOG® PROGRESSIVE-LINE Implants FDA UDI
- Model / Reference
- C5300.9015 EUDAMEDFDA UDI
- Description
- X-Ray planning foil 1.4:1, CONELOG® PROGRESSIVE-LINE Implants FDA UDI
Identifiers
- Catalog Number
- C5300.9015 FDA UDI
- Primary DI / UDI-DI
- 04099797009293 EUDAMEDE219C530090151 FDA UDI
- Basic UDI-DI
- 40997970008010000000000H8 EUDAMED
- Secondary DI
- E219C530090151 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
No
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 22f4b675-c27a-4070-87e9-d0e96ec49716 61 fields · synced May 31, 2026
- FDA UDI 4b02c5f3-e185-4021-a41e-dafc5c639113 35 fields · synced May 30, 2026