510(k) K852743

PORCELAIN VENEER SYSTEM LABORATORY KIT by The S. S. White Co. — Product Code EIH

K852743 is an FDA 510(k) premarket notification submitted by The S. S. White Co. for the device "PORCELAIN VENEER SYSTEM LABORATORY KIT". The FDA issued a decision of Substantially Equivalent on July 31, 1985. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. The S. S. White Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1985
Date Received
June 27, 1985
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