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Temporary Abutement

FDA UDI

Class II (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name
Temporary Abutement FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Ø5.9, L:11.75mm FDA UDI
Model / Reference
DEWTAH FDA UDI
Description
Ø5.9, L:11.75mm FDA UDI

Identifiers

Primary DI / UDI-DI
08806169105479 FDA UDI
510(k) Number
K082843 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Temporary Abutement by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K082843 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentis Co. , Ltd

Sources (1)

  • FDA UDI 880d9564-3e3b-412d-b0b4-e2cc6683eba0 35 fields · synced Jun 1, 2026