510(k) K102456

INTRAORAL BELSENSOR GOLD by Takara Belmont USA, Inc. — Product Code MUH

K102456 is an FDA 510(k) premarket notification submitted by Takara Belmont USA, Inc. for the device "INTRAORAL BELSENSOR GOLD". The FDA issued a decision of Substantially Equivalent on December 15, 2011. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Takara Belmont USA, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2011
Date Received
August 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type