Sapphire® Plus

FDA UDI

Class II (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name: Sapphire® Plus FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: LT SAPPHIRE LOANER FDA UDI
Model / Reference: 033958000L FDA UDI
Description: LT SAPPHIRE LOANER FDA UDI

Identifiers

Catalog Number: 033958000L FDA UDI
Primary DI / UDI-DI: D813033958000L0 FDA UDI
510(k) Number: K081287 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 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

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/surgical polymerization lamp

Sapphire® Plus by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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VALO — ULTRADENT PRODUCTS, INC. · Class II

Cleared under the same submission

K081287 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Den-Mat Holdings, LLC

Sources (1)

FDA UDI e3e3a002-103b-43cb-a2e6-b70eea7bd874 37 fields · synced Jun 9, 2026