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American Dental

FDA UDI

Class I (US FDA UDI)

by Hu-Friedy Mfg Co., Llc

Identity

Trade Name
AMERICAN DENTAL FDA UDI
Generic Name
Endodontic plugger FDA UDI
Device Name
DEXL Lemian 11-12 V Cond Posterior FDA UDI
Model / Reference
3E0893 FDA UDI
Description
DEXL Lemian 11-12 V Cond Posterior FDA UDI

Identifiers

Catalog Number
3E0893 FDA UDI
Primary DI / UDI-DI
10889950123321 FDA UDI
FDA Product Code
EKR FDA UDI
GMDN Term
Endodontic plugger 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endodontic plugger

American Dental by Hu-Friedy Mfg Co., Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic plugger.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 0a0b7cc3-0013-4d6a-9866-4e99f5406f4c 35 fields · synced May 31, 2026