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EdgeTip™ #3

FDA UDI

Class II (US FDA UDI)

by Edge Endo Llc

Identity

Trade Name
EdgeTip™ #3 FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Device Name
Diamond-coated retreatment tip for the removal of very hard materials in the first crown FDA UDI
Model / Reference
ET20D FDA UDI
Description
Diamond-coated retreatment tip for the removal of very hard materials in the first crown FDA UDI

Identifiers

Primary DI / UDI-DI
00818365020164 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic

EdgeTip™ #3 by Edge Endo Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece tip, endodontic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edge Endo Llc

Sources (1)

  • FDA UDI 847149fd-c965-4c8c-9244-557c0f5855b7 33 fields · synced May 30, 2026