s-Clean ScanBody Screw
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- s-Clean ScanBody Screw EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / s-Clean ScanBody Screw FDA UDI
- Model / Reference
- DSSBS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMED
- Description
- Dental Implant Instrument / s-Clean ScanBody Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053014885 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES 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
s-Clean ScanBody Screw by Dentis 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
- Dentis Co. , Ltd
Sources (2)
- FDA UDI 4c355077-5b47-4d56-9544-d37589627421 33 fields · synced Jul 10, 2026
- EUDAMED 0b0473a1-4e62-4174-ae13-2e4a0814cc41 61 fields · synced Jul 10, 2026