i-Clean ScanBody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- i-Clean ScanBody EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / DISBS FDA UDIDental Implant Instrument / DISBWL FDA UDIDental Implant Instrument / DISBWLS FDA UDIDental Implant Instrument / DISBWSS FDA UDI
- Model / Reference
- DISBWL EUDAMEDFDA UDIDISBWLS EUDAMEDFDA UDIDISBWSS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDISBS FDA UDI
- Description
- Dental Implant Instrument / DISBS FDA UDIDental Implant Instrument / DISBWL FDA UDIDental Implant Instrument / DISBWLS FDA UDIDental Implant Instrument / DISBWSS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053040457 EUDAMEDFDA UDI08800053040525 EUDAMEDFDA UDI08800053040518 EUDAMEDFDA UDI08800053040426 FDA 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
i-Clean ScanBody 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 (7)
- FDA UDI 9d894aa2-902e-4181-a3ac-3787845a46cf 33 fields · synced Jul 20, 2026
- FDA UDI c9168b05-62ad-408c-b460-2343630e1e79 33 fields · synced May 24, 2026
- FDA UDI 705340a6-5802-4d8e-93d9-6b91688126d4 33 fields · synced May 29, 2026
- FDA UDI 872e60c7-98ca-49b2-9a11-007c3fc68052 33 fields · synced May 30, 2026
- EUDAMED be6ddd5e-b969-4d3b-a1d0-eaead70f532f 61 fields · synced Jul 9, 2026
- EUDAMED d3888ee4-7e90-485e-86cd-14b80b3db0e6 61 fields · synced Jul 10, 2026
- EUDAMED d7c6f44d-3ceb-4ccc-a9ff-dd6e63303bdb 61 fields · synced Jul 20, 2026