i-Clean Temporary Abutment

FDA UDI

Class II (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name: i-Clean Temporary Abutment FDA UDI
Generic Name: Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name: i-Clean Temporary Abutment (DIPTW20O) FDA UDI
Model / Reference: DIPTW20O FDA UDI
Description: i-Clean Temporary Abutment (DIPTW20O) FDA UDI

Identifiers

Primary DI / UDI-DI: 08800053080804 FDA UDI
510(k) Number: K230307 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, temporary, preformed, single-use

DENTIS CO. LTD.'s i-Clean Temporary Abutment (DIPTW20O) is a prefabricated dental implant suprastructure designed for temporary use during restorative and laboratory procedures. This single-use device provides a critical intermediate level of support between an implant and temporary prosthesis/restoration, facilitating oral soft-tissue healing and sculpting before final fabrication/rehabilitation. With its various features, including burnout/temporary cylinders, fixture impression pick-ups, and replica devices, the i-Clean Temporary Abutment is ideal for specific dental applications.

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Cleared under the same submission

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 e634ef3b-9314-44db-b523-02805520af23 34 fields · synced Jul 6, 2026

i-Clean Temporary Abutment

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)