AccessGUDID - DEVICE: Fantastic-M Contact Cure Orthodontic Adhesive (D83610131)

GUDID

Device Identifier (DI) Information

Brand Name: Fantastic-M Contact Cure Orthodontic Adhesive
Version or Model: 1013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1013
Company Name: DENT ZAR, INC.

Primary DI Number: D83610131
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789664455 *Terms of Use

Device Description: Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, thus saving the dentist chair time. This procedure can also minimize erratic mixing procedures, and therefore reducing the possibility of errors caused by paste inconsistencies, a problem often encountered in other types of adhesives. Fantastic M has strong, reliable bond, mistake-proof cure-on-touch system: fast and easy to use, color stable and it economical in application. Fantastic-M starts to set only after the bracket is applied to the tooth, giving the operator the convenience and security of virtually unlimited working time. This material is very reliable due to its outstanding adhesive properties. Also, due to the soft filler, Fantastic-M is easy to clean. The material is highly tacky, therefore, brackets will not slide after being placed on the tooth, but rather they will remain immobilized until the material cures. Delayed cure time permits the operator to correct the position of the brackets up to 15 seconds after placement. Fantastic-M is very economical, unlike conventional adhesives that are normally mixed in excess.

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?
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. 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 [?]
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: 0613b96a-afb6-4bb2-98b2-248fed937ae7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 03, 2016