FUSION Grand Curing Light

FDA UDI

Class II (US FDA UDI)

by Dentlight Inc.

Identity

Trade Name: FUSION Grand Curing Light FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: FUSION Grand Curing Light FDA UDI
Model / Reference: 7830080 FDA UDI
Description: FUSION Grand Curing Light FDA UDI

Identifiers

Catalog Number: 7830080 FDA UDI
Primary DI / UDI-DI: 00860179001068 FDA UDI
510(k) Number: K180065 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/surgical polymerization lamp

FUSION Grand Curing Light by Dentlight Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental/surgical polymerization lamp.

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VALO — ULTRADENT PRODUCTS, INC. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
VALO — ULTRADENT PRODUCTS, INC. · Class II
Coltolux — Coltene/Whaledent Inc. · Class II
Ascent PX Charging Station — CAO GROUP, INC. · Class II

Cleared under the same submission

K180065 also covers:

FUSION Plus Curing Light — DENTLIGHT INC.

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: Dentlight Inc.

Sources (1)

FDA UDI 198c0263-48dd-43a6-80be-efd15741b746 37 fields · synced Jun 1, 2026