Amtouch Etchant Gel

Basic Information

• Brand Name: Amtouch Etchant Gel
• Primary DI: 00850048528994
• Version / Model: 1.2ml (24 pack)
• Catalog Number: AMETCH24
• Company Name: AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
• Labeler DUNS: 180611519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-15
• Public Version: 2
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: d558cf7a-dd72-47c4-abcd-7cf6dc1fa169

Device Description

Amtouch Etchant Gel 37%, Medium Viscosity, 1.2ml (24x Syringes)

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: Yes
• 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
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36153	Dental tooth-etching solution	An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. 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	00850048528994	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Special Storage