510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920492Substantially Equivalent

High Vac

Hygoplastic, Inc., Grafton WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920492 is the FDA 510(k) clearance record for HIGH VAC, a class I device, cleared for Hygoplastic, Inc. on under FDA product code DYN (Mouthpiece, Saliva Ejector). FDA records list one 510(k) clearance for Hygoplastic, Inc. As of , FDA records show no recalls naming K920492.

Clearance record

Decision date
Received
(98 days to decision)
Product code
DYN Mouthpiece, Saliva Ejector
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Hygoplastic, Inc. 1494 Lakeshore Rd., Grafton WI
510(k) summary
Statement
Third party review
No

Clearances, product code DYN

Trailing 12 months

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

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