← Back to catalogue
i-Clean Excellent Solid Abutment Lab Analog
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DIESLA40Model DENTIS Implant Surgical Instrument SystemRef DIESLA30
Identity
- Trade Name
- i-Clean Excellent 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 Excellent Solid Abutment Lab Analog FDA UDI
- Model / Reference
- DIESLA30 EUDAMEDFDA UDIDIESLA40 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMED
- Description
- Dental Implant Instrument / i-Clean Excellent Solid Abutment Lab Analog FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053039000 EUDAMEDFDA UDI08800053039017 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 Excellent Solid Abutment Lab Analog 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 analog.
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM — DIO Corporation · Class I
- One Stage TL S — I3 IMPLANT LLC · Class II
- Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
- Implant Analog 6mm Trilobe Stainless Steel — Sterngold Dental LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (4)
- FDA UDI 74aa614b-18a7-49e6-a8ac-d5c24894aa05 33 fields · synced Jul 18, 2026
- FDA UDI f94ef19f-d6ee-4926-b1b1-b33da67f66d6 33 fields · synced May 30, 2026
- EUDAMED 07a90fdd-32d2-45af-b45c-9862011144b8 61 fields · synced Jul 15, 2026
- EUDAMED fea6644a-7274-46e2-9d82-cca5d6f1cdc1 61 fields · synced Jul 18, 2026