i-Clean Solid Positioning Cylinder
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- i-Clean Solid Positioning Cylinder EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / i-Clean Solid Positioning Cylinder FDA UDI
- Model / Reference
- DISIPCW EUDAMEDFDA UDIDISIPCR EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDISIPCW65 FDA UDI
- Description
- Dental Implant Instrument / i-Clean Solid Positioning Cylinder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053039369 EUDAMEDFDA UDI08800053039352 EUDAMEDFDA UDI08800053039376 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 suprastructure, temporary, preformed, 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 suprastructure, temporary, preformed, single-use
i-Clean Solid Positioning Cylinder by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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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 (5)
- FDA UDI 0356e589-dea4-457e-b849-26958c3f9341 33 fields · synced Jul 9, 2026
- FDA UDI 093a3894-b86f-4d0c-ab76-4c28486463ac 33 fields · synced May 30, 2026
- FDA UDI 77124e2c-119d-49da-a893-67a3cd323344 33 fields · synced May 30, 2026
- EUDAMED 863091c8-4e0a-4cec-9775-60a1999d82f2 61 fields · synced Jun 20, 2026
- EUDAMED 19430b45-9945-4ef8-8536-55974222a474 61 fields · synced Jul 9, 2026