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EdgeSurgicalTip™ #2

FDA UDI

Class II (US FDA UDI)

by Edge Endo Llc

Identity

Trade Name
EdgeSurgicalTip™ #2 FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Device Name
Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterior FDA UDI
Model / Reference
AS3D2 FDA UDI
Description
Universal diamond-coated apical surgery tip for the retro-preparation of canals of anterior FDA UDI

Identifiers

Primary DI / UDI-DI
00818365020102 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

EdgeSurgicalTip™ #2 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 2c80e675-f2de-4efd-80f1-409326639f90 33 fields · synced May 30, 2026