Scan abutment Non-Engaging Ø 4, 1 H 10.0
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Scan abutment Non-Engaging Ø 4,1 H 10.0 EUDAMEDIPD FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Scan abutment EUDAMEDScan abutment Non-Engaging Ø 4,1 H 10.0 FDA UDI
- Model / Reference
- SC3D / SC / SCH / SCOS / SCFL / SCLQ / SCR EUDAMEDIPD/BB-SR-01 EUDAMEDSC3D FDA UDI
- Description
- Scan abutment Non-Engaging Ø 4,1 H 10.0 FDA UDI
Identifiers
- Catalog Number
- IPD/BB-SR-01 FDA UDI
- Primary DI / UDI-DI
- 08435566606021 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435566608C2 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
Scan abutment Non-Engaging Ø 4, 1 H 10.0 by Implant Protesis Dental 2004 S.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- 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 | 8435566608C2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Implant Protesis Dental 2004 S.l.
- EUDAMED SRN
- ES-MF-000002195
Sources (2)
- EUDAMED 43c1a086-bdea-45a3-b14d-f64379a0c1e2 61 fields · synced Jun 18, 2026
- FDA UDI a6a61944-5ae0-49f1-b1ae-06d4ac1f3f04 35 fields · synced May 30, 2026