AccessGUDID - DEVICE: IN-OVATION® C (D807K100552821)

GUDID

Device Identifier (DI) Information

Brand Name: IN-OVATION® C
Version or Model: K100-552-82
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K100-552-82
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D807K100552821
Issuing Agency: HIBCC
Commercial Distribution End Date: February 19, 2021
Device Count: 16
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58818	Self-ligating orthodontic bracket	A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. 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
NJM	Bracket, ceramic, orthodontic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 82beed68-2210-49bf-a0b7-0c1f475cf259
Public Version Date: March 01, 2024
Public Version Number: 5
DI Record Publish Date: June 26, 2017