Temrex Satin Polishing Paste

FDA UDI

Class I (US FDA UDI)

by Temrex Corp.

Identity

Trade Name: TEMREX SATIN POLISHING PASTE FDA UDI
Generic Name: Dentifrice FDA UDI
Device Name: For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both intra and extra oral use. FDA UDI
Model / Reference: 5200, 5210 FDA UDI
Description: For restoring the original smoothness and polishing of dental porcelain crowns, inlays, onlays, veneers and bridges; for both intra and extra oral use. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850015110474 FDA UDI
510(k) Number: K852157 FDA UDI
FDA Product Code: EJR FDA UDI
GMDN Term: Dentifrice 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Dentifrice

Temrex Satin Polishing Paste by Temrex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dentifrice.

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Dental City — ICP, INC. · Class I
Blasting Powder — Bioclear Matrix Systems, LLC · Class I
Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
Prophy Brush — Huanghua Promisee Dental Co.Ltd. · 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: Temrex Corp.

Sources (1)

FDA UDI fd94fb4d-1e36-40f5-8e5c-33f27ca93deb 34 fields · synced May 31, 2026