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i-Clean Solid Abutment Lab Analog
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DISLAW70Model DENTIS Implant Surgical Instrument SystemRef DISLA30Ref DISLA55Ref DISLAW40Ref DISLA70
Identity
- Trade Name
- i-Clean Solid Abutment Lab Analog EUDAMEDFDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / i-Clean Solid Abutment Lab Analog FDA UDI
- Model / Reference
- DISLAW40 EUDAMEDFDA UDIDISLA70 EUDAMEDFDA UDIDISLAW70 EUDAMEDFDA UDIDISLA30 EUDAMEDFDA UDIDISLA55 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMED
- Description
- Dental Implant Instrument / i-Clean Solid Abutment Lab Analog FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053038973 EUDAMEDFDA UDI08800053038966 EUDAMEDFDA UDI08800053038997 EUDAMEDFDA UDI08800053038935 EUDAMEDFDA UDI08800053038959 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 analog 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 analog
i-Clean Solid Abutment Lab Analog 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
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 (10)
- FDA UDI f90351f6-a3d8-4502-95ab-27750d15aaf9 33 fields · synced Sep 17, 2026
- FDA UDI f2a4c96f-9beb-4d56-b52b-2bff1844d9a0 33 fields · synced May 30, 2026
- FDA UDI 55372c5c-a1cb-47aa-b0c4-da06e4ea0c05 33 fields · synced May 30, 2026
- FDA UDI ee0f803c-0b26-4b70-b1e6-d78ef1c1b840 33 fields · synced May 30, 2026
- FDA UDI bc66cbde-d659-4fc3-b77e-e4e005150393 33 fields · synced May 30, 2026
- EUDAMED 34352e9c-137e-485e-af3c-63da2cdaee0a 61 fields · synced Jul 9, 2026
- EUDAMED 9ad84ac7-f391-4f25-9db2-5a6cf178cb7c 61 fields · synced Jul 23, 2026
- EUDAMED 0077f2bb-b619-4945-b0be-84ed64f19c3d 61 fields · synced Jul 29, 2026
- EUDAMED 6ddb5956-f258-49a2-8d7d-8043d4d2a2bf 61 fields · synced Aug 1, 2026
- EUDAMED 29813f3e-b843-46a0-bddf-b19ea425c491 61 fields · synced Sep 17, 2026