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Ceka M3 Space Maint. 0.3mm 10 Pcs
EUDAMEDFDA UDIClass I (EU MDR)
Ref 694 BModel 694B
by Alphadent NV
Identity
- Trade Name
- CEKA M3 SPACE MAINT. 0.3MM 10 PCS EUDAMEDCEKA & PRECI-LINE ATTACHMENTS FDA UDI
- Generic Name
- Bar dental precision attachment FDA UDI
- Device Name
- CEKA M3 SPACE MAINTAINER EUDAMEDCEKA M3 SPACE MAINT. 0.3MM 10 PCS FDA UDI
- Model / Reference
- 694B EUDAMED694 B EUDAMEDFDA UDI
- Description
- CEKA M3 SPACE MAINT. 0.3MM 10 PCS FDA UDI
Identifiers
- Catalog Number
- 694 B FDA UDI
- Primary DI / UDI-DI
- 14260576941630 EUDAMEDFDA UDI
- Basic UDI-DI
- 426057694694B4G EUDAMED
- Direct Marketing DI
- 14260576941630 EUDAMED
- FDA Product Code
- EGG FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Bar dental precision attachment FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 0.3 Millimeter FDA UDI
Ceka M3 Space Maint. 0.3mm 10 Pcs by Alphadent NV — 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 | 426057694694B4G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alphadent NV
- EUDAMED SRN
- BE-MF-000000923
Sources (2)
- EUDAMED 022da619-b030-4acd-9334-9b88b59d13df 61 fields · synced Jul 19, 2026
- FDA UDI f2de886a-a331-41e4-874b-8d49e0fc5819 36 fields · synced May 30, 2026