Clearance Summary
S-53 INTRORAL DENTAL SYSTEM received FDA 510(k) clearance under submission number K962979, sponsored by Del Medical Systems Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-09-25.
- Submission: K962979
- Applicant / Sponsor: Del Medical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4130
- Decision date: 1996-09-25
Classification & Regulation
This clearance is catalogued under FDA product code DZA and 21 CFR 872.4130, within the Dental review panel as a Class I device.