i-Clean Solid Impression Cap
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- i-Clean Solid Impression Cap EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment impression cap FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / i-Clean Solid Impression Cap FDA UDI
- Model / Reference
- DISICW65 EUDAMEDFDA UDIDISICR EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMED
- Description
- Dental Implant Instrument / i-Clean Solid Impression Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169143099 EUDAMEDFDA UDI08806169143075 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 impression cap 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 impression cap
i-Clean Solid Impression Cap 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 (4)
- FDA UDI 49a6ccd0-2dc0-4f27-b7d2-ace7ee27a6f0 33 fields · synced Jul 24, 2026
- FDA UDI 909ce86c-614f-470a-8fee-f268527dfd19 33 fields · synced May 30, 2026
- EUDAMED 2238bbdb-5b33-444e-8077-75a9eb8a35c5 61 fields · synced Jul 10, 2026
- EUDAMED 3bdd8256-9081-49af-ba60-ae6c7c82188d 61 fields · synced Jul 24, 2026