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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 6012 Tip FDA UDI
Model / Reference
EEDPUT6012 FDA UDI
Description
EdgePack 6012 Tip FDA UDI

Identifiers

Catalog Number
EEDPUT6012 FDA UDI
Primary DI / UDI-DI
00810988031480 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

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 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

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Manufacturer

Manufacturer
Handpiece Parts & Repairs, Inc.

Sources (1)

  • FDA UDI 1ef4166e-45c9-49b8-998f-abfa7049f6e0 34 fields · synced Jun 6, 2026