AccessGUDID - DEVICE: UniFil® (D6584210011)

GUDID

Device Identifier (DI) Information

Brand Name: UniFil®
Version or Model: 421001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 421001
Company Name: Gc America Inc.

Primary DI Number: D6584210011
Issuing Agency: HIBCC
Commercial Distribution End Date: August 27, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: UniFil® UniFil Bond Starter Kit (1 x 6mL bottle of UniFil Bond Self-Etching Primer, 1 x 6mL bottle of UniFil Bonding agent & accessories)

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
KLE	AGENT, TOOTH BONDING, RESIN

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
Storage Environment Temperature: between 36 and 46.4 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0288ded4-be1c-4721-8b24-7faa68d7d559
Public Version Date: February 16, 2024
Public Version Number: 4
DI Record Publish Date: August 01, 2016