ZENITH™ ROTH COMPOSITE BRACKETS - ZENITH™ ROTH CMP UPR LT 1ST BIC W/HK 018, -7°T, - G & H WIRE COMPANY, INC.

Duns Number:831465641

Device Description: ZENITH™ ROTH CMP UPR LT 1ST BIC W/HK 018, -7°T, 0°AZenith™ Series Composite [CM] aesthetic ZENITH™ ROTH CMP UPR LT 1ST BIC W/HK 018, -7°T, 0°AZenith™ Series Composite [CM] aesthetic brackets are precision designed and manufactured so that no special treatment mechanics or bonding procedures are necessary. All of the same clinical techniques routinely used with metal brackets are applicable with Zenith™.Zenith™ brackets are designed with all the features needed to achieve contemporary treatment objectives including rounded contours for comfort and reduced friction, sweeping tie wing undercuts, notched bases for mechanical bonds, plus many more.

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More Product Details

Catalog Number

-

Brand Name

ZENITH™ ROTH COMPOSITE BRACKETS

Version/Model Number

RCMUL419-V

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

K973776,K973776

Product Code Details

Product Code

DYW

Product Code Name

Bracket, Plastic, Orthodontic

Device Record Status

Public Device Record Key

685f28d4-a8ff-4a26-ab8c-c81a1dac961b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"G & H WIRE COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 288