Clearance Summary
ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS received FDA 510(k) clearance under submission number K952628, 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 1995-10-19.
- Submission: K952628
- Applicant / Sponsor: Elastomade Accessories Sdn Bhd
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 1995-10-19
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.