Quala

Basic Information

• Brand Name: Quala
• Primary DI: D023Q400042ML1
• Version / Model: Q400042ML
• Catalog Number: Q400042ML
• Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.
• Labeler DUNS: 009831413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-25
• Public Version: 4
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: 22630867-b24f-4e30-a383-63470cc7fd7c

Device Description

Quala Etch Gel 2ml Syringe 4 Syringes 20 Tips

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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 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
Previous	D023Q4000418	HIBCC
Primary	D023Q400042ML1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K941899	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 77 Degrees Fahrenheit