Scanner, Color

Device Code: 1304

Product Code(s): KZN

Device Classification Information

• Device Type ID: 1304
• Device Name: Scanner, Color
• Regulation Description: Optical Impression Systems For CAD/CAM.
• 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: 872.3661 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KZN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-256 ADA ANSI Standard No. 132 - 2015
  Scanning Accuracy Of Dental Chairside And Laboratory CAD/CAM Systems

Total Product Life Cycle

• Device Type ID: 1304
• Device: Scanner, Color
• Product Code: KZN
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Optical Impression Systems For CAD/CAM.
• CFR Regulation Number: 872.3661 [🔎]

TPLC Last Update: 2019-04-02 19:51:41