AccessGUDID - DEVICE: Custom I Q (D798CIQA0)

GUDID

Device Identifier (DI) Information

Brand Name: Custom I Q
Version or Model: CIQA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CIQA
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798CIQA0
Issuing Agency: HIBCC
Commercial Distribution End Date: May 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.

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:	No
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?
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYH	Adhesive, Bracket And Tooth Conditioner, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K880791	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
Special Storage Condition, Specify: TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b8b555d-24eb-4282-a54d-c060aa1cb22c
Public Version Date: February 16, 2024
Public Version Number: 5
DI Record Publish Date: July 25, 2016