Clearance Summary
DENTAL EQUIPMENT PROTECTION DEVICES received FDA 510(k) clearance under submission number K891216, sponsored by Pro-Safe Professional Linens, 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 1989-06-02.
- Submission: K891216
- Applicant / Sponsor: Pro-Safe Professional Linens, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4630
- Decision date: 1989-06-02
Classification & Regulation
This clearance is catalogued under FDA product code EAZ and 21 CFR 872.4630, within the Dental review panel as a Class I device.