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Edta

FDA UDI

Class U (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name
EDTA FDA UDI
Generic Name
Endodontic reaming aid material FDA UDI
Device Name
EDTA 18% Bottle 16oz FDA UDI
Model / Reference
4616 FDA UDI
Description
EDTA 18% Bottle 16oz FDA UDI

Identifiers

Catalog Number
4616 FDA UDI
Primary DI / UDI-DI
00883205106711 FDA UDI
510(k) Number
K934415 FDA UDI
FDA Product Code
KJJ FDA UDI
GMDN Term
Endodontic reaming aid material FDA UDI

Classification

Device Class
U 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

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

No

FDA UDI

Category: Endodontic reaming aid material

Edta by Ultradent Products, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic reaming aid material.

Cleared under the same submission

K934415 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ultradent Products, Inc.

Sources (1)

  • FDA UDI 4e6551d4-d8ac-4b8b-ae08-5dd6f8da8d6a 37 fields · synced May 30, 2026