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TruAbutment DS

FDA UDI

Class II (US FDA UDI)

by TruAbutment Inc.

Identity

Trade Name
TruAbutment DS FDA UDI
Generic Name
Dental implant suprastructure, permanent, custom-made FDA UDI
Model / Reference
KPW-CB FDA UDI

Identifiers

Catalog Number
KPW-CB FDA UDI
Primary DI / UDI-DI
08800076447134 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, custom-made 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, permanent, custom-made

TruAbutment DS by TruAbutment Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, permanent, custom-made.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
TruAbutment Inc.

Sources (1)

  • FDA UDI acee6b80-fef9-48ee-8002-dcd37b38b54a 34 fields · synced May 30, 2026