510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801386Substantially Equivalent

Pre-Dent System or Pre-Dent II

Pre-Dent System, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801386 is the FDA 510(k) clearance record for PRE-DENT SYSTEM OR PRE-DENT II, a class I device, cleared for Pre-Dent System on under FDA product code KSS (Supplies, Blood-Bank). FDA records list 3 510(k) clearances for Pre-Dent System, from to . As of , FDA records show no recalls naming K801386.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KSS Supplies, Blood-Bank
Regulation
21 CFR 864.9050
Device class
Class I
Review panel
Hematology
Applicant
Pre-Dent System 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSS

Trailing 12 months

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

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