S/ETCH

Basic Information

• Brand Name: S/ETCH
• Primary DI: 09336472011963
• Version / Model: 8100045
• Catalog Number: 8100045
• Company Name: SDI LIMITED
• Labeler DUNS: 753221852
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-08
• Public Version: 2
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: da6f5f3d-fb98-4913-9fe6-a82e901be97e

Device Description

S/ETCH 10X2ML SYR KT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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 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	09336472011963	GS1

Premarket Submissions

Submission Number	Supplement Number
K941899	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 10°C - 25°C (50 - 77°F) Recommended Cool Room Storage (10°C - 18°C)