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: PLUGGERS/CONDENSERS PLGB1/2 SERRATED FDA UDI
Model / Reference: 2308S FDA UDI
Description: PLUGGERS/CONDENSERS PLGB1/2 SERRATED FDA UDI

Identifiers

Catalog Number: 2308S FDA UDI
Primary DI / UDI-DI: D9432308S00 FDA UDI
FDA Product Code: EKR 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 Endodontic plugger Dental amalgam carrier

A comprehensive hand-held dental spatula designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This device is reusable and has a flat-tipped end.

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Also classified as Dental amalgam carrier.

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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 337c74fa-9364-4ce9-9d8c-7ba300c4b6e8 35 fields · synced Jul 8, 2026