Positioner, Tooth, Preformed

Device Code: 1288

Product Code(s): KMY

Device Classification Information

• Device Type ID: 1288
• Device Name: Positioner, Tooth, Preformed
• Regulation Description: Preformed Tooth Positioner.
• 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) Exempt
• CFR Regulation Number: 872.5525 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KMY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 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: 1288
• Device: Positioner, Tooth, Preformed
• Product Code: KMY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Preformed Tooth Positioner.
• CFR Regulation Number: 872.5525 [🔎]

Device Problems
Break	2
Device Appears To Trigger Rejection	1
Patient-Device Incompatibility	1
Total Device Problems	4

TPLC Last Update: 2019-04-02 19:51:24