OVC3 Hybrid - The OVC3 Hybrid Molar Kit consists of a set of 12 - RHONDIUM LIMITED

Duns Number:595078345

Device Description: The OVC3 Hybrid Molar Kit consists of a set of 12 OVCs in tooth shade A2 -one each for 4 t The OVC3 Hybrid Molar Kit consists of a set of 12 OVCs in tooth shade A2 -one each for 4 tooth types, upper and lower molar, in three sizes for each tooth type individually packaged. Each OVC Hybrid is packaged with 2 x OVC Wedges, 2 x Stretch Wedges, a Selector Key, 2 x OVC3 Matrix Band, 1 x Hex Stick and an OVC Hybrid Replica.

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More Product Details

Catalog Number

9421031795474

Brand Name

OVC3 Hybrid

Version/Model Number

OVC3 Hybrid Molar Kit A2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2019

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

-

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

c87266e8-4c1d-4d60-9956-331eedd5bcba

Public Version Date

March 28, 2019

Public Version Number

5

DI Record Publish Date

February 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RHONDIUM LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 407