Power Dental USA

FDA UDI

Class I (US FDA UDI)

by Power Dental USA, Inc.

Identity

Trade Name: Power Dental USA FDA UDI
Generic Name: Dental excavator, reusable FDA UDI
Device Name: SCALERS 204 FDA UDI
Model / Reference: 1207 FDA UDI
Description: SCALERS 204 FDA UDI

Identifiers

Catalog Number: 1207 FDA UDI
Primary DI / UDI-DI: D94312070 FDA UDI
FDA Product Code: EMN FDA UDI
GMDN Term: Dental excavator, 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

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Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual dental scaler, reusable Dental excavator, reusable

A comprehensive medical device directory featuring the Power Dental USA dental excavator, a reusable hand-held instrument designed for cutting, scraping, and removing carious dentine or pathological bone tissue within the oral cavity. Learn more about its features, compliance, and regulatory status.

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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 62380b33-f44f-4d5f-ab8a-fc20130fd31a 35 fields · synced Jul 2, 2026