Clear Blue

Basic Information

• Brand Name: Clear Blue
• Primary DI: 00862314000301
• Version / Model: Digi 2.0
• Company Name: JOHNSON-PROMIDENT
• Labeler DUNS: 965230188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-24
• Public Version: 3
• Public Version Date: 2022-02-28
• Public Version Status: Update
• Public Device Record Key: 7f03ffe5-8942-4efa-9947-6968213dd05f

Device Description

LED curing light

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
EBZ	Activator, Ultraviolet, For Polymerization	Dental	872.6070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35761	Dental laboratory curing unit	A mains electricity (AC-powered) device used in the dental laboratory for curing polymer-based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. For a curing light used chairside see the appropriate GMDN code.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862314000301	GS1

Premarket Submissions

Submission Number	Supplement Number
K172426	000