Bracket, Plastic, Orthodontic, Reprocessed

Device Code: 1341

Product Code(s): NLC

Definition: Same As DYW Except It Is Being Reprocessed

Device Classification Information

• Device Type ID: 1341
• Device Name: Bracket, Plastic, Orthodontic, Reprocessed
• Regulation Description: Orthodontic Plastic Bracket.
• 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: 872.5470 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NLC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-218 ISO 27020 First Edition 2010-12-15
  Dentistry - Brackets And Tubes For Use In Orthodontics

Total Product Life Cycle

• Device Type ID: 1341
• Device: Bracket, Plastic, Orthodontic, Reprocessed
• Product Code: NLC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Orthodontic Plastic Bracket.
• CFR Regulation Number: 872.5470 [🔎]

TPLC Last Update: 2019-04-02 19:52:20