SUPER-SNAP

Basic Information

• Brand Name: SUPER-SNAP
• Primary DI: 04548162235381
• Version / Model: L525
• Catalog Number: L525
• Company Name: SHOFU DENTAL CORPORATION
• Labeler DUNS: 054618202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-03
• Public Version: 2
• Public Version Date: 2022-10-19
• Public Version Status: Update
• Public Device Record Key: 7b58ea9b-a6f8-482e-b085-a1556bae891e

Device Description

SUPER SNAP POLYSTRIPS, BK/VT 1

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHL	POINT, ABRASIVE	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35702	Dental abrasive strip, single-use	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04548162235381	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 1 – 10 Degrees Celsius