i-Clean Plastic Cylinder
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- i-Clean Plastic 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 Plastic Cylinder FDA UDIi-Clean Plastic Cylinder (DIOPWO) FDA UDI
- Model / Reference
- DIOPWO EUDAMEDFDA UDIDIOPO EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDIOPN FDA UDI
- Description
- Dental Implant Instrument / i-Clean Plastic Cylinder FDA UDIi-Clean Plastic Cylinder (DIOPWO) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053040167 EUDAMEDFDA UDI08800053023047 EUDAMEDFDA UDI08800053023030 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 Plastic 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 d3e95935-47c7-4da9-af5b-5a86843c714a 33 fields · synced Jul 10, 2026
- FDA UDI 3e778330-d147-4583-a762-b310ff203c8c 33 fields · synced May 30, 2026
- FDA UDI 8a17658a-7746-411f-b92a-d8c6843f5fd3 33 fields · synced May 30, 2026
- EUDAMED 06d139f5-a8ac-4ade-9883-a19ab40e41a0 61 fields · synced Jul 9, 2026
- EUDAMED c7c9711f-9111-45ab-88b2-4df04df3ef4e 61 fields · synced Jul 10, 2026