AccessGUDID - DEVICE: ALPHA-DENT® Porcelain Conditioner (D73554201010010)

GUDID

Device Identifier (DI) Information

Brand Name: ALPHA-DENT® Porcelain Conditioner
Version or Model: 542.0101.001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 542.0101.001
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73554201010010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: ALPHA-DENT® Porcelain Conditioner permits bonding versatility with patients that have bridgework or crowns. This conditioner is a silane coupling agent, which helps to chemically bond the adhesive to porcelain.

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?
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 [?]
K921044	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: eabe250f-7d27-4858-962f-7cb32a8a7efe
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016