AccessGUDID - DEVICE: IN-OVATION® R (D807K189017081)

GUDID

Device Identifier (DI) Information

Brand Name: IN-OVATION® R
Version or Model: K189-017-08
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K189-017-08
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D807K189017081
Issuing Agency: HIBCC
Commercial Distribution End Date: February 19, 2021
Device Count: 20
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: IN-OVATION® R CCO® 018 U 5-5/L5-5 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":	No
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?
46581	Orthodontic bracket, metal	A metallic device that is bonded to an orthodontic band, or directly 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
EJF	BRACKET, METAL, ORTHODONTIC

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 7092d8e8-c7df-4db8-ab2e-b2f24de132c2
Public Version Date: February 22, 2021
Public Version Number: 3
DI Record Publish Date: September 30, 2019