AccessGUDID - DEVICE: FUSION Silane (D8370620010)

GUDID

Device Identifier (DI) Information

Brand Name: FUSION Silane
Version or Model: A - 6 oz
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06-2001
Company Name: Taub Products

Primary DI Number: D8370620010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth.

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):	No
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?
35877	Dental repair kit, ceramic	A packaged collection of devices used for the repair of fractured porcelain veneers. This kit is used by a dentist and may include etching gel or liquid, bonding material, silanization liquid, a polymer-based restorative material (composite) and several other devices. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBO	Denture Repair Kit

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
Special Storage Condition, Specify: Keep away from open flame. See SDS.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 6 Fluid Ounce

Device Record Status

Public Device Record Key: 006acc3c-d731-4b2b-b2fa-42a77c6a10a1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 26, 2016