MDC Dental - Tone C1. Box wit: 2 10:1 cartridge with 70g (50 - MDC DENTAL

Duns Number:811180298

Device Description: Tone C1. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + disp Tone C1. Box wit: 2 10:1 cartridge with 70g (50 ml) + 20 mixing tips + instructions + dispenser gun. It is used in the elaboration of all kinds of temporary dental Provisionals: inlays, onlays, veneers, bridges and partial or total crowns.It can be used as a filling / relining material for precast and temporary composite and metal crowns.

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More Product Details

Catalog Number

-

Brand Name

MDC Dental

Version/Model Number

Bisacryl Nictone C1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991577

Product Code Details

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

775bf7a3-6495-45ce-94e6-bcc7fa85736e

Public Version Date

December 28, 2021

Public Version Number

1

DI Record Publish Date

December 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MDC DENTAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 46