510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821364Substantially Equivalent

Proflex Flexible Scaler

Teledyne Densco, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821364 is the FDA 510(k) clearance record for PROFLEX FLEXIBLE SCALER, a class I device, cleared for Teledyne Densco on under FDA product code EHM (Strip, Polishing Agent). FDA records list 4 510(k) clearances for Teledyne Densco, from to . As of , FDA records show no recalls naming K821364.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EHM Strip, Polishing Agent
Regulation
21 CFR 872.6010
Device class
Class I
Review panel
Dental
Applicant
Teledyne Densco 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EHM

Trailing 12 months

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

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