LW Scan Body SET
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LW Scan Body EUDAMEDLW Scan Body SET FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Scan body EUDAMEDDental Implant Accessories - Scan Body FDA UDI
- Model / Reference
- LWDSB4516HS EUDAMEDFDA UDILWDSB4508HS EUDAMED
- Description
- Dental Implant Accessories - Scan Body FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809918250185 EUDAMEDFDA UDI
- Basic UDI-DI
- 880987741LI0032JE 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
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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 abutment analog, intraoral-scanning, single-use
LW Scan Body SET by Ossvis Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ossvis Co., Ltd.
Sources (2)
- FDA UDI 6f7a523b-4e18-42b8-a987-596ef28994ac 33 fields · synced Oct 8, 2026
- EUDAMED 4452bb9b-91c4-4292-9511-f0e6588f9cb7 61 fields · synced Oct 8, 2026