Luminary-3D Dental

FDA UDI

Class II (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name: Luminary-3D Dental FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: LUMINARY LED CURING LIGHT FDA UDI
Model / Reference: LED FDA UDI
Description: LUMINARY LED CURING LIGHT FDA UDI

Identifiers

Primary DI / UDI-DI: 00817169021391 FDA UDI
510(k) Number: K001719 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

FDA UDI

Category: Dental/surgical polymerization lamp

Luminary-3D Dental by 3d Dental Designs And Development, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K001719 also covers:

LL-LED-II — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
TPC — TPC ADVANCE TECHNOLOGY, INC.
TPC — TPC ADVANCE TECHNOLOGY, INC.
TPC — TPC ADVANCE TECHNOLOGY, INC.
TPC — TPC ADVANCE TECHNOLOGY, INC.
TPC — TPC ADVANCE TECHNOLOGY, INC.
TPC — TPC ADVANCE TECHNOLOGY, INC.
TPC — TPC ADVANCE TECHNOLOGY, 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: 3d Dental Designs And Development, Llc

Sources (1)

FDA UDI bcdb88b1-0480-415a-a3f3-5f088305c68b 34 fields · synced Jun 8, 2026