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Pre-Coated TiBase 1PK, Integrated Thread

FDA UDI

Class I (US FDA UDI)

by Smart Denture Conversions, Llc

Identity

Trade Name
Pre-Coated TiBase 1PK, Integrated Thread FDA UDI
Generic Name
Dental prosthesis/implant abutment screw analog, single-use FDA UDI
Model / Reference
PTB1PK-IT FDA UDI

Identifiers

Primary DI / UDI-DI
D990PTB1PKIT0 FDA UDI
FDA Product Code
NDP FDA UDI
EJX FDA UDI
GMDN Term
Dental prosthesis/implant abutment screw analog, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
872.3130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Dental implant suprastructure, temporary, preformed, single-useDental prosthesis/implant abutment screw analog, single-use

Pre-Coated TiBase 1PK, Integrated Thread by Smart Denture Conversions, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis/implant abutment screw analog, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smart Denture Conversions, Llc

Sources (1)

  • FDA UDI 6b3e481a-6639-4120-8bc7-f4eb05d13512 33 fields · synced May 30, 2026