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: Manual dental scaler, reusable FDA UDI
Device Name: SICKLE SCALERS J1/2 FDA UDI
Model / Reference: N1309 FDA UDI
Description: SICKLE SCALERS J1/2 FDA UDI

Identifiers

Catalog Number: N1309 FDA UDI
Primary DI / UDI-DI: D943N1309 FDA UDI
FDA Product Code: EMN FDA UDI
GMDN Term: Manual dental scaler, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual dental scaler, reusable

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Power Dental USA, Inc.

Sources (1)

FDA UDI c82c274e-d192-4f3e-95c1-f56f0dedce78 35 fields · synced Jun 8, 2026