SPEC 3 Clear Light Guide, 11mm Straight Tip

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 60013951

by Coltene/Whaledent Inc.

Identity

Trade Name: SPEC 3 Clear Light Guide, 11mm Straight Tip EUDAMED
SPEC 3 FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: LED Curing Lights EUDAMED
SPEC 3 Clear Light Guide, 11mm Straight Tip FDA UDI
Model / Reference: 60013951 EUDAMEDFDA UDI
Description: SPEC 3 Clear Light Guide, 11mm Straight Tip FDA UDI

Identifiers

Primary DI / UDI-DI: D661600139510 EUDAMEDFDA UDI
Basic UDI-DI: ++D661076L2 EUDAMED
FDA Product Code: EBZ FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 872.6070 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental appliance fabrication material, ceramic

SPEC 3 Clear Light Guide, 11mm Straight Tip by Coltene/Whaledent Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++D661076L2	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Coltene/Whaledent Inc.
EUDAMED SRN: US-MF-000015761
Authorised Representative: Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Sources (2)

EUDAMED b19c2002-1069-4f99-97c3-2ae8822eefd1 61 fields · synced Jul 19, 2026
FDA UDI d9074da5-159a-42a3-93ff-0ea2f767f0a6 34 fields · synced May 29, 2026