Stimulator, Salivary System

Device Code: 1313

Product Code(s): LTF

Device Classification Information

• Device Type ID: 1313
• Device Name: Stimulator, Salivary System
• Regulation Description: Electrical Salivary Stimulatory System.
• Regulation Medical Specialty: Dental
• 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)
• CFR Regulation Number: 872.5560 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LTF
• 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: 1313
• Device: Stimulator, Salivary System
• Product Code: LTF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Electrical Salivary Stimulatory System.
• CFR Regulation Number: 872.5560 [🔎]

Premarket Reviews
Manufacturer	Decision
SALIWELL LTD.
	SUBSTANTIALLY EQUIVALENT	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Howmedica Osteonics Corp.	II	Aug-08-2018

TPLC Last Update: 2019-04-02 19:51:50