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Quala

FDA UDI

Class I (US FDA UDI)

by National Distribution & Contracting, Inc.

Identity

Trade Name
QUALA FDA UDI
Generic Name
Dental polishing cup, single-use FDA UDI
Device Name
QUALA DISP PROPHY ANGLES SOFT CUP 144/BX (521514) FDA UDI
Model / Reference
P1029 FDA UDI
Description
QUALA DISP PROPHY ANGLES SOFT CUP 144/BX (521514) FDA UDI

Identifiers

Catalog Number
P1029 FDA UDI
Primary DI / UDI-DI
D023P10297 FDA UDI
FDA Product Code
EGS FDA UDI
GMDN Term
Dental polishing cup, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental polishing cup, single-use

Quala by National Distribution & Contracting, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental polishing cup, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
National Distribution & Contracting, Inc.

Sources (1)

  • FDA UDI 59638cd8-87a5-4e3c-b8fc-2410a85fd977 34 fields · synced Jun 8, 2026