Clearance Summary
JEJE TEETHER received FDA 510(k) clearance under submission number K034017, sponsored by Vibe 2000. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-10-18.
- Submission: K034017
- Applicant / Sponsor: Vibe 2000
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5550
- Decision date: 2004-10-18
Classification & Regulation
This clearance is catalogued under FDA product code MEF and 21 CFR 872.5550, within the Dental review panel as a Class I device.