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: CORD PACKER GCPS 171 NON SERRATED FDA UDI
Model / Reference: 3121 FDA UDI
Description: CORD PACKER GCPS 171 NON SERRATED FDA UDI

Identifiers

Catalog Number: 3121 FDA UDI
Primary DI / UDI-DI: D94331210 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's CORD PACKER GCPS 171 NON SERRATED is a hand-held manual dental instrument designed for manipulating filling materials in the plastic state. This reusable device features a unique design with various forms of fine ridged cutting surfaces at its working end(s) and is typically made of stainless steel or titanium (Ti). It is suitable for use in a variety of clinical settings, including dentistry and other medical specialties.

Similar devices

Also classified as Dental amalgam carrier.

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Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I
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 4e615184-5a32-41ce-a138-590b9b6f79f3 35 fields · synced Aug 1, 2026