Safco Fluora Trays

Basic Information

• Brand Name: Safco Fluora Trays
• Primary DI: D72301273223
• Version / Model: 1027322
• Catalog Number: 1027322
• Company Name: SAFCO DENTAL SUPPLY CO.
• Labeler DUNS: 020417380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-11-21
• Public Version: 1
• Public Version Date: 2022-11-29
• Public Version Status: New
• Public Device Record Key: 3173c474-36ee-4837-a4e4-0280523b22f4

Device Description

Safco Fluora flouride trays, small, yellow, 100/pkg

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMT	TRAY, FLUORIDE, DISPOSABLE	Dental	872.6870	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63350	Teeth whitening tray	A custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D72310273220	HIBCC
Primary	D72301273223	HIBCC