510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K051056Substantially Equivalent

Verify Self-Contained Biological Indicator

Sybron Dental Specialties, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051056 is the FDA 510(k) clearance record for VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR, a class II device, cleared for Albert Browne , Ltd. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 176 510(k) clearances for Sybron Dental Specialties, Inc., from to . As of , FDA records show no recalls naming K051056.

Clearance record

Decision date
Received
(177 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Albert Browne , Ltd. 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRC

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