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Power Dental U.S.A., Inc.

FDA UDI

Class I (US FDA UDI)

by Power Dental USA, Inc.

Identity

Trade Name
Power Dental U.S.A., Inc. FDA UDI
Generic Name
Endodontic plugger FDA UDI
Device Name
ENDO NITI K 35# SIZE 32.5+.-. 0.5mm. 2% taper . Handpiece 0.68 - 0.71mm . pkg of 6 FDA UDI
Model / Reference
N3434 FDA UDI
Description
ENDO NITI K 35# SIZE 32.5+.-. 0.5mm. 2% taper . Handpiece 0.68 - 0.71mm . pkg of 6 FDA UDI

Identifiers

Catalog Number
N3434 FDA UDI
Primary DI / UDI-DI
D943N3434 FDA UDI
FDA Product Code
EKR FDA UDI
GMDN Term
Endodontic plugger FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Power Dental U.S.A., Inc. by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Power Dental USA, Inc.

Sources (1)

  • FDA UDI ee2e6350-0bea-4bdb-b8c9-24b8d9da576a 36 fields · synced May 30, 2026