AccessGUDID - DEVICE: ZENITH™ ROTH COMPOSITE BRACKETS (10190886009642)

GUDID

Device Identifier (DI) Information

Brand Name: ZENITH™ ROTH COMPOSITE BRACKETS
Version or Model: RCML522-V
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: G & H Wire Company, Inc.

Primary DI Number: 10190886009642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 831465641 *Terms of Use

Device Description: ZENITH™ ROTH CMP LWR 2ND BIC UNIV 022, -22°T, 0°A Zenith™ 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46582	Orthodontic bracket, plastic, single-use	A plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYW	Bracket, Plastic, Orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973776	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba3fd05b-c190-4b4b-9bef-e99224a3fb63
Public Version Date: January 31, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016