Impression Tools/Analogues + Space Maintainers For M3 Size - 2+2 Pcs.
EUDAMEDFDA UDIClass I (EU MDR)
by Alphadent NV
Identity
- Trade Name
- IMPRESSION TOOLS/ANALOGUES + SPACE MAINTAINERS FOR M3 SIZE - 2+2 PCS. EUDAMEDCEKA & PRECI-LINE ATTACHMENTS FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- CEKA M3 MODEL ANALOGUE EUDAMEDM3 IMPRESSION TOOL FEMALE 2 PCS FDA UDI
- Model / Reference
- H 14 EUDAMEDFDA UDI
- Description
- M3 IMPRESSION TOOL FEMALE 2 PCS FDA UDI
Identifiers
- Catalog Number
- H 14 FDA UDI
- Primary DI / UDI-DI
- 04260576941817 EUDAMEDFDA UDI
- Basic UDI-DI
- 426057694H14FD EUDAMED
- Direct Marketing DI
- 04260576941817 EUDAMED
- FDA Product Code
- EGG FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Steel dental bur, reusable 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Impression Tools/Analogues + Space Maintainers For M3 Size - 2+2 Pcs. by Alphadent NV — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426057694H14FD | 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 894b7613-2b68-49dd-88d1-00bd0f0d3c43 61 fields · synced Jun 18, 2026
- FDA UDI 4f97d657-1f4b-468e-af7a-c554b363ba6a 36 fields · synced May 30, 2026