Spec 3

FDA UDI

Class II (US FDA UDI)

by Coltene/Whaledent Inc.

Identity

Trade Name: SPEC 3 FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: SPEC 3 LED Plug UK FDA UDI
Model / Reference: 60019065 FDA UDI
Description: SPEC 3 LED Plug UK FDA UDI

Identifiers

Primary DI / UDI-DI: D661600190650 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental/surgical polymerization lamp

Spec 3 by Coltene/Whaledent Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Coltene/Whaledent Inc.

Sources (1)

FDA UDI e833b635-7b46-4ec3-9ae9-abd29a395065 34 fields · synced Jun 9, 2026