OVC3 Hybrid - OVC3 Hybrid Starter - Molar & Premolar Kit - RHONDIUM LIMITED

Duns Number:595078345

Device Description: OVC3 Hybrid Starter - Molar & Premolar Kit consists of a set of 24 OVCs in tooth shade A3 OVC3 Hybrid Starter - Molar & Premolar Kit consists of a set of 24 OVCs in tooth shade A3 - one each for 8 tooth types, upper and lower molar and premolars, in three sizes for each tooth type individually packaged. Each OVC3 Hybrid is packaged with 2 x OVC Wedges, 2 x Stretch Wedges, a Selector Key, 2 x OVC3 Matrix Band, and an OVC3 Hybrid Replica.

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More Product Details

Catalog Number

9421031796860

Brand Name

OVC3 Hybrid

Version/Model Number

OVC3 Hybrid Starter Kit - Molar & Premolar A3

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

K143694

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

4b488693-1c6e-4a95-a7cb-915e1b369c1a

Public Version Date

March 22, 2019

Public Version Number

1

DI Record Publish Date

March 14, 2019

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