510(k) K102305

HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P by Hass Corp. — Product Code EIH

K102305 is an FDA 510(k) premarket notification submitted by Hass Corp. for the device "HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P". The FDA issued a decision of Substantially Equivalent on December 3, 2010. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Hass Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
August 16, 2010
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