Cleanser, Root Canal

Device Code: 1399

Product Code(s): KJJ

Device Classification Information

• Device Type ID: 1399
• Device Name: Cleanser, Root Canal
• Review Panel: Dental
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Dental Devices Branch (DEDB)
• Submission Type: 510(k)
• FDA Device Classification: Class Unclassified Medical Device
• Product Code: KJJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1399
• Device: Cleanser, Root Canal
• Product Code: KJJ

Premarket Reviews
Manufacturer	Decision
ESSENTIAL DENTAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSTITUT STRAUMANN AG
	SUBSTANTIALLY EQUIVALENT	1
OCULUS INNOVATIVE SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
PAC-DENT INC.
	SUBSTANTIALLY EQUIVALENT	3
STRAUMANN
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Patient-Device Incompatibility	2
Human-Device Interface Problem	1
Use Of Device Problem	1
Overfill	1
Total Device Problems	5

TPLC Last Update: 2019-04-02 19:53:27