Alpha-Etch® 37

Basic Information

• Brand Name: Alpha-Etch® 37
• Primary DI: D73550100060020
• Version / Model: 501.0006.002
• Catalog Number: 501.0006.002
• Company Name: DENTAL TECHNOLOGIES, INC.
• Labeler DUNS: 148312838
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5ee352d3-06bf-4990-881c-bae9247b6f4b

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 (Green), 20 Syringe Tips

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D73550100060020	HIBCC
Unit of Use	D73550102040020	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K984503	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius