Identity
- Trade Name
- i-Clean Excellent Solid Abutment Healig Cap FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, metal FDA UDI
- Device Name
- Dental Implant System / i-Clean Healing Cap D5.9mm X L5.5mm / Excellent Solid FDA UDI
- Model / Reference
- DIESHC30 FDA UDI
- Description
- Dental Implant System / i-Clean Healing Cap D5.9mm X L5.5mm / Excellent Solid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169105080 FDA UDI
- 510(k) Number
- K171027 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
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: Extra-gynaecological surgical mesh, metal
i-Clean Excellent Solid Abutment Healig Cap by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, metal.
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- OSSEOGUARD® — BIOMET 3I, LLC · Class II
- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Cleared under the same submission
K171027 also covers:
- e-Clean Cemented Abutment — DENTIS CO. , LTD
- e-Clean Cemented Abutment — DENTIS CO. , LTD
- e-Clean Cemented Abutment — DENTIS CO. , LTD
- e-Clean Cemented Abutment — DENTIS CO. , LTD
- e-Clean Cemented Abutment — DENTIS CO. , LTD
- e-Clean Cemented Abutment — DENTIS CO. , LTD
- e-Clean Cemented Abutment — DENTIS CO. , LTD
- e-Clean Healing Abutment — DENTIS CO. , LTD
- e-Clean Healing Abutment — DENTIS CO. , LTD
- i-Clean Free Abutment — DENTIS CO. , LTD
- i-Clean Gold Cylinder — DENTIS CO. , LTD
- i-Clean Gold UCLA Abutment — DENTIS CO. , LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (1)
- FDA UDI 47f21891-0cc3-4bc4-b709-ca61faf0eb2b 34 fields · synced Jun 8, 2026