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Dental City

FDA UDI

Class I (US FDA UDI)

by Icp, Inc.

Identity

Trade Name
Dental City FDA UDI
Generic Name
Endodontic enlarger, single-use FDA UDI
Device Name
K-Files 31mm #08 FDA UDI
Model / Reference
39-700 FDA UDI
Description
K-Files 31mm #08 FDA UDI

Identifiers

Primary DI / UDI-DI
D77139700 FDA UDI
FDA Product Code
EKQ FDA UDI
GMDN Term
Endodontic enlarger, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

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: Endodontic enlarger, single-use

Dental City by Icp, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic enlarger, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icp, Inc.

Sources (1)

  • FDA UDI 896310cd-3fcc-4b10-b53f-fee96230d471 33 fields · synced May 30, 2026