510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864300Substantially Equivalent

Siliva Ejector/oral Cavity Evacuator

Ardent Intl., Inc., Newtown Square PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864300 is the FDA 510(k) clearance record for SILIVA EJECTOR/ORAL CAVITY EVACUATOR, a class I device, cleared for Ardent Intl., Inc. on under FDA product code DYN (Mouthpiece, Saliva Ejector). FDA records list 3 510(k) clearances for Ardent Intl., Inc., from to . As of , FDA records show no recalls naming K864300.

Clearance record

Decision date
Received
(24 days to decision)
Product code
DYN Mouthpiece, Saliva Ejector
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Ardent Intl., Inc. 165 Mansion Rd., Newtown Square PA
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