Device, Jaw Repositioning

Device Code: 1311

Product Code(s): LQZ

Device Classification Information

• Device Type ID: 1311
• Device Name: Device, Jaw Repositioning
• Regulation Description: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea.
• 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: 872.5570 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LQZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

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)]
• 4-233 ISO 20795-2 Second Edition 2013-03-01
  Dentistry - Base Polymers - Part 2: Orthodontic Base Polymers
• 4-234 ADA ANSI Standard No. 139-2012
  Dental Base Polymers

Total Product Life Cycle

• Device Type ID: 1311
• Device: Device, Jaw Repositioning
• Product Code: LQZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea.
• CFR Regulation Number: 872.5570 [🔎]

Premarket Reviews
Manufacturer	Decision
SELANE PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Insufficient Information	3
Total Device Problems	3

TPLC Last Update: 2019-04-02 19:51:47