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Quala

FDA UDI

Class II (US FDA UDI)

by National Distribution & Contracting, Inc.

Identity

Trade Name
Quala FDA UDI
Generic Name
Dental etching solution FDA UDI
Device Name
Quala Etch Gel Econo Kit 12-1.2ML Gel 50 Tips FDA UDI
Model / Reference
Q40012 FDA UDI
Description
Quala Etch Gel Econo Kit 12-1.2ML Gel 50 Tips FDA UDI

Identifiers

Catalog Number
Q40012 FDA UDI
Primary DI / UDI-DI
D23Q4001217 FDA UDI
510(k) Number
K941899 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dental etching solution FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

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

Cleared under the same submission

K941899 also covers:

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 3ce84ce3-5dfb-4322-adf2-0e1a82673b97 37 fields · synced Jun 1, 2026