Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Non-sterile

Device Code: 1345

Product Code(s): NOB

Definition: Manual Toothbrush; See Product Code MCF

Device Classification Information

• Device Type ID: 1345
• Device Name: Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Non-sterile
• Regulation Description: Manual Toothbrush.
• 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: 872.6855 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: NOB
• GMP Exempt: Yes
• 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: 1345
• Device: Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Non-sterile
• Product Code: NOB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Toothbrush.
• CFR Regulation Number: 872.6855 [🔎]

TPLC Last Update: 2019-04-02 19:52:24