G-CAM - 98.5 Monochroma 24NBL1 - GRAPHENANO DENTAL SL.

Duns Number:467167850

Device Description: 98.5 Monochroma 24NBL1

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More Product Details

Catalog Number

-

Brand Name

G-CAM

Version/Model Number

GC00222

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

Yes

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

K220329

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

6e185cf2-5f91-4a08-ac89-50205e9fd63d

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRAPHENANO DENTAL SL." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 320