510(k) K132102
K132102 is an FDA 510(k) premarket notification submitted by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO for the device "BECE CAD ZIRKON HT+". The FDA issued a decision of Substantially Equivalent on November 12, 2013. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2013
- Date Received
- July 8, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type