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Apoza

FDA UDI

Class I (US FDA UDI)

by Apoza Enterprise Co., Ltd.

Identity

Trade Name
APOZA FDA UDI
Generic Name
Endodontic obturation system FDA UDI
Device Name
GP obturation device is applied to professional dentistry, which cuts off and softens root canal filling material for making it more easily filled into all places inside root canal during root canal treatment. FDA UDI
Model / Reference
GP Easy II FDA UDI
Description
GP obturation device is applied to professional dentistry, which cuts off and softens root canal filling material for making it more easily filled into all places inside root canal during root canal treatment. FDA UDI

Identifiers

Primary DI / UDI-DI
04719883751300 FDA UDI
FDA Product Code
EKR FDA UDI
GMDN Term
Endodontic obturation system 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

No

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

Yes

FDA UDI

Category: Endodontic obturation system

Apoza by Apoza Enterprise Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic obturation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apoza Enterprise Co., Ltd.

Sources (1)

  • FDA UDI 23d4d80b-f8e5-4a7b-914a-0ce014727edc 33 fields · synced Jun 1, 2026