Identity
- Trade Name
- s-Clean Healing Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Implant System / s-Clean Healing Abutment D7.0mm X L9.5mm FDA UDI
- Model / Reference
- DSH70156 FDA UDI
- Description
- Dental Implant System / s-Clean Healing Abutment D7.0mm X L9.5mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169133700 FDA UDI
- 510(k) Number
- K171027 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
s-Clean Healing Abutment by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (1)
- FDA UDI 1310d1a7-2d54-4888-b2af-9e18e3066f8b 34 fields · synced May 30, 2026