Clearance Summary
TEMPOCEM received FDA 510(k) clearance under submission number K110759, sponsored by Dmg USA, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-06-10.
- Submission: K110759
- Applicant / Sponsor: Dmg USA, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3275
- Decision date: 2011-06-10
Classification & Regulation
This clearance is catalogued under FDA product code EMB and 21 CFR 872.3275, within the Dental review panel as a Class I device.