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i-Clean Solid Type PS Abutment
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DPIA15Model DENTIS Implant Surgical Instrument SystemRef DPIS40
Identity
- Trade Name
- i-Clean Solid Type PS Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment trial FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / i-Clean Solid Type PS Abutment FDA UDI
- Model / Reference
- DPIS40 EUDAMEDFDA UDIDPIA15 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDPIS70 FDA UDI
- Description
- Dental Implant Instrument / i-Clean Solid Type PS Abutment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169139689 EUDAMEDFDA UDI08806169139801 EUDAMEDFDA UDI08806169139702 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 trial 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant abutment trial
i-Clean Solid Type PS Abutment by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant abutment trial.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 65111920-f2ab-4a3f-8056-e17b31d2317c 33 fields · synced Jul 26, 2026
- FDA UDI 59d07e74-9ad2-420d-9b79-4ef1a2ba6175 33 fields · synced May 30, 2026
- FDA UDI 649e40c7-7b01-4303-a0a3-dd9d49809f66 33 fields · synced May 30, 2026
- EUDAMED 2af5b969-3b61-4940-aa91-706982a0d9f6 61 fields · synced Jul 25, 2026
- EUDAMED da9f2f7e-9b84-4bbc-be55-3bd7e92c1e57 61 fields · synced Jul 26, 2026