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Pindex

FDA UDI

Class I (US FDA UDI)

by Coltene/Whaledent Inc.

Identity

Trade Name
Pindex FDA UDI
Generic Name
Dental laboratory power tool system FDA UDI
Device Name
1000 Self-Articulating Sleeves FDA UDI
Model / Reference
PX145S FDA UDI
Description
1000 Self-Articulating Sleeves FDA UDI

Identifiers

Primary DI / UDI-DI
D661PX145S1 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental laboratory power tool system FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental laboratory power tool system

Pindex by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental laboratory power tool system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coltene/Whaledent Inc.

Sources (1)

  • FDA UDI 7a76e480-40fc-465a-8656-6f7971930187 33 fields · synced Jun 9, 2026