510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882183Substantially Equivalent

Dental Burs

Tri-Stage, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882183 is the FDA 510(k) clearance record for DENTAL BURS, a class I device, cleared for Tri-Stage, Inc. on under FDA product code EJL (Bur, Dental). FDA records list 3 510(k) clearances for Tri-Stage, Inc., from to . As of , FDA records show no recalls naming K882183.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EJL Bur, Dental
Regulation
21 CFR 872.3240
Device class
Class I
Review panel
Dental
Applicant
Tri-Stage, Inc. 5897 Oberlin Dr. #205, San Diego CA
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