AccessGUDID - DEVICE: ALPHA-DENT® Paste & Paste Orthodontic Adhesive (D73530200000010)

GUDID

Device Identifier (DI) Information

Brand Name: ALPHA-DENT® Paste & Paste Orthodontic Adhesive
Version or Model: 302.0000.001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 302.0000.001
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73530200000010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: ALPHA-DENT® Paste & Paste Orthodontic Adhesive is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimizes bonding failures. Kit Contains: 14g Catalyst Paste, 14g Base Paste, 1x 7ml Catalyst Bracket Bonding Resin, 1 x 7ml Base Bracket Bonding Resin, 7ml Etch Liquid, Spatulas, Mixing Pads

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:	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
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930614	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
Storage Environment Temperature: between 2 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00e94042-7b70-48a0-9815-ee58d89f004c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016