510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071615Substantially Equivalent

Fixafloss

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

K071615 is the FDA 510(k) clearance record for FIXAFLOSS, a class I device, cleared for Sybron Dental Specialties, Inc. on under FDA product code EEF (Clamp, Rubber Dam). FDA records list 176 510(k) clearances for Sybron Dental Specialties, Inc., from to . As of , FDA records show no recalls naming K071615.

Clearance record

Decision date
Received
(100 days to decision)
Product code
EEF Clamp, Rubber Dam
Regulation
21 CFR 872.6300
Device class
Class I
Review panel
Dental
Applicant
Sybron Dental Specialties, Inc. 1717 W. Collins Ave., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EEF

Trailing 12 months

FDA records hold no clearances under product code EEF in the trailing twelve months.

FDA records show no clearances under product code EEF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EEF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260