AccessGUDID - DEVICE: Alpha-Etch® 37 (D73550100050020)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha-Etch® 37
Version or Model: 501.0005.002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501.0005.002
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73550100050020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: Alpha-Etch® 37 is a 37% phosphoric acid etchant designed for use on both dentin and enamel. The ideal viscosity of the gel formula stays where placed and will not flow onto exposed surrounding tissue. All formulas rinse away clean without leaving any residue. Available in blue and green color. Kit Contains: 4 x 4g Syringe (Blue), 20 Syringe Tips

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?
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. 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 [?]
K984503	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: b44581fe-f2c7-4783-bd5e-8cebadb0f830
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016