Identity
- Trade Name
- Common scan body screw EUDAMEDScan body FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Scan body EUDAMED
- Model / Reference
- LD-BSM-PT EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932195325443 EUDAMEDFDA UDI
- Basic UDI-DI
- 69321953SMT5B 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
- 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Common scan body screw by Chengdu Besmile Medical Technology Co., Ltd. — 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 | 69321953SMT5B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Chengdu Besmile Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025929
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 8dfe315a-ee6c-4dc5-93d0-59ec332d37b2 61 fields · synced Jul 17, 2026
- FDA UDI b912ddf9-0349-4f42-a18f-83596308e910 32 fields · synced May 30, 2026