Clearance Summary
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES received FDA 510(k) clearance under submission number K905470, sponsored by Elastomade Accessories Sdn Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-04-25.
- Submission: K905470
- Applicant / Sponsor: Elastomade Accessories Sdn Bhd
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 1991-04-25
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.