510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780377Substantially Equivalent

Pinidentoflex Dental Polisher

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

K780377 is the FDA 510(k) clearance record for PINIDENTOFLEX DENTAL POLISHER, a class I device, cleared for Cavitron Corp. on under FDA product code EHL (Point, Abrasive). FDA records list 32 510(k) clearances for Cavitron Corp., from to . As of , FDA records show no recalls naming K780377.

Clearance record

Decision date
Received
(6 days to decision)
Product code
EHL Point, Abrasive
Regulation
21 CFR 872.6010
Device class
Class I
Review panel
Dental
Applicant
Cavitron Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EHL

Trailing 12 months

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

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