← Back to catalogue

Edge Endo

FDA UDI

Class I (US FDA UDI)

by Handpiece Parts & Repairs, Inc.

Identity

Trade Name
EDGE ENDO FDA UDI
Generic Name
Endodontic obturation system handpiece, heat conducting FDA UDI
Device Name
EdgePack Downpack Unit FDA UDI
Model / Reference
EEDPU FDA UDI
Description
EdgePack Downpack Unit FDA UDI

Identifiers

Catalog Number
EEDPU FDA UDI
Primary DI / UDI-DI
00810988031374 FDA UDI
FDA Product Code
EKR FDA UDI
GMDN Term
Endodontic obturation system handpiece, heat conducting 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endodontic obturation system handpiece, heat conducting

Edge Endo by Handpiece Parts & Repairs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic obturation system handpiece, heat conducting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Handpiece Parts & Repairs, Inc.

Sources (1)

  • FDA UDI d7fe6812-5608-4518-aa6a-9f15c662c8a1 34 fields · synced May 30, 2026