510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163064Substantially Equivalent

Demi Ultra

Sybron Dental Specialties, Inc., Orange CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163064 is the FDA 510(k) clearance record for Demi Ultra, a class II device, cleared for Kerr Corporation on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 176 510(k) clearances for Sybron Dental Specialties, Inc., from to . As of , FDA records show no recalls naming K163064.

Clearance record

Decision date
Received
(258 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Kerr Corporation 1717 W. Collins Ave., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBZ

Trailing 12 months
1 clearance under product code EBZ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260