PWR Classic Powder Mint

FDA UDI

Class I (US FDA UDI)

by Prisman Inc.

Identity

Trade Name: PWR Classic Powder Mint FDA UDI
Generic Name: Professional dental abrasive material FDA UDI
Device Name: Sodium bicarbonate prophylaxis powder (40µ) for the supragingival removal of intractable plaque and discolorations on enamel. FDA UDI
Model / Reference: AP-CM FDA UDI
Description: Sodium bicarbonate prophylaxis powder (40µ) for the supragingival removal of intractable plaque and discolorations on enamel. FDA UDI

Identifiers

Primary DI / UDI-DI: 04064896000557 FDA UDI
FDA Product Code: EJR FDA UDI
GMDN Term: Professional dental abrasive material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Professional dental abrasive material

PWR Classic Powder Mint by Prisman 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: Prisman Inc.

Sources (1)

FDA UDI 7bd36be3-8bd1-4749-bbc9-0483152d1d2d 33 fields · synced Jun 6, 2026