Luminary-3D Dental - LUMINARY LED CURING LIGHT - 3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Duns Number:080194935

Device Description: LUMINARY LED CURING LIGHT

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More Product Details

Catalog Number

-

Brand Name

Luminary-3D Dental

Version/Model Number

LED

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K001719

Product Code Details

Product Code

EBZ

Product Code Name

Activator, Ultraviolet, For Polymerization

Device Record Status

Public Device Record Key

bcdb88b1-0480-415a-a3f3-5f088305c68b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3D DENTAL DESIGNS AND DEVELOPMENT, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 142
U Unclassified 1