510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080687Substantially Equivalent

Smartburs

SS White Burs LLC, Lakewood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K080687 is the FDA 510(k) clearance record for SMARTBURS, a class I device, cleared for S.S. White Burs, Inc. on under FDA product code EJL (Bur, Dental). FDA records list one 510(k) clearance for S.S. White Burs, Inc. As of , FDA records show no recalls naming K080687.

Clearance record

Decision date
Received
(101 days to decision)
Product code
EJL Bur, Dental
Regulation
21 CFR 872.3240
Device class
Class I
Review panel
Dental
Applicant
S.S. White Burs, Inc. 1145 Towbin Ave., Lakewood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EJL

Trailing 12 months

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

FDA records show no clearances under product code EJL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJL, 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