GEL ETCH

Basic Information

• Brand Name: GEL ETCH
• Primary DI: 00850015110375
• Version / Model: 6500 KIT
• Company Name: TEMREX CORPORATION
• Labeler DUNS: 012072823
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-12
• Public Version: 1
• Public Version Date: 2020-02-20
• Public Version Status: New
• Public Device Record Key: 855c7468-362e-4122-8c9b-245e4b86ae4c

Device Description

DENTAL ETCHING PREPARATORY MATERIAL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
EBF	Material, Tooth Shade, Resin	Dental	872.3690	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	00850015110375	GS1

Premarket Submissions

Submission Number	Supplement Number
K872569	000