Clearance Summary
DENTAL MIRROR RETRACTOR received FDA 510(k) clearance under submission number K885040, sponsored by Nu-Lite Retractor, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-01-10.
- Submission: K885040
- Applicant / Sponsor: Nu-Lite Retractor, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1989-01-10
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.