510(k) K924830
K924830 is an FDA 510(k) premarket notification submitted by Dmg Chemisch Pharmazeutische Fabrik GmbH for the device "LUXATEMP AUTOMIX". The FDA issued a decision of Substantially Equivalent on Apr 29, 1994. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Dmg Chemisch Pharmazeutische Fabrik GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 29, 1994
- Date Received
- Sep 25, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type
- 510(k)