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Gpro

FDA UDI

Class I (US FDA UDI)

by Beyes Dental Canada Inc

Identity

Trade Name
GPRO FDA UDI
Generic Name
Endodontic obturation system handpiece, heat conducting FDA UDI
Device Name
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper FDA UDI
Model / Reference
GP2003 FDA UDI
Description
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper FDA UDI

Identifiers

Catalog Number
GPRO P1 FDA UDI
Primary DI / UDI-DI
00990010302211 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Endodontic obturation system handpiece, heat conducting

Gpro by Beyes Dental Canada 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
Beyes Dental Canada Inc

Sources (1)

  • FDA UDI 5dad3e28-5830-4b6c-9ef4-a1e6eacfa903 34 fields · synced May 30, 2026