Clearance Summary
SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER received FDA 510(k) clearance under submission number K973513, sponsored by Espe GmbH & Co. Kg.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-12-22.
- Submission: K973513
- Applicant / Sponsor: Espe GmbH & Co. Kg.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 1997-12-22
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.