510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K923020Substantially Equivalent

Cleanic

Hawe Neos Dental, Switzerland, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923020 is the FDA 510(k) clearance record for CLEANIC, a class I device, cleared for Hawe Neos Dental on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list one 510(k) clearance for Hawe Neos Dental. As of , FDA records show no recalls naming K923020.

Clearance record

Decision date
Received
(78 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Hawe Neos Dental Dr.. H.V. Weissenfluh Ag, Switzerland, CH
510(k) summary
Statement
Third party review
No

Clearances, product code EJR

Trailing 12 months

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

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