Saliva, Artificial

Device Code: 1400

Product Code(s): LFD

Device Classification Information

• Device Type ID: 1400
• Device Name: Saliva, Artificial
• 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: LFD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]

Total Product Life Cycle

• Device Type ID: 1400
• Device: Saliva, Artificial
• Product Code: LFD

Premarket Reviews
Manufacturer	Decision
ELEVATE ORAL CARE
	SUBSTANTIALLY EQUIVALENT	1
EUSA PHARMA (UK) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FORWARD SCIENCE LLC
	SUBSTANTIALLY EQUIVALENT	1
LACLEDE, INC.
	SUBSTANTIALLY EQUIVALENT	1
YOU FIRST SERVICES, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Insufficient Information	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:53:29