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 spatula, reusable FDA UDI
Device Name: PLASTIC FILLING PFI G FDA UDI
Model / Reference: 3004 FDA UDI
Description: PLASTIC FILLING PFI G FDA UDI

Identifiers

Catalog Number: 3004 FDA UDI
Primary DI / UDI-DI: D9433004 FDA UDI
FDA Product Code: EIY FDA UDI
GMDN Term: Dental spatula, 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: Dental spatula, reusable Margin finishing dental file/rasp, reusable Dental amalgam carrier

Power Dental USA is a hand-held manual dental device used to manipulate filling materials in the plastic state, typically made of stainless steel with a small, flat, blunt blade at one end. This reusable instrument is designed for specific tasks such as collecting, transporting and depositing amalgam into prepared cavities or smoothing and shaping teeth.

Similar devices

Also classified as Dental amalgam carrier.

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SurgiMac — Surgimac LLC · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
Buffalo Dental Mfg — Buffalo Dental Manufacturing Co., Inc. · Class I
Buffalo Dental Mfg — Buffalo Dental Manufacturing Co., Inc. · Class I

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 e1f4849a-feea-4b25-b20a-a5e20641ba49 35 fields · synced Jul 3, 2026