Clearance Summary
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT received FDA 510(k) clearance under submission number K120695, sponsored by Dentist IN A Box Pty., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-06-12.
- Submission: K120695
- Applicant / Sponsor: Dentist IN A Box Pty., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3275
- Decision date: 2012-06-12
Classification & Regulation
This clearance is catalogued under FDA product code EMB and 21 CFR 872.3275, within the Dental review panel as a Class I device.