510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921117Substantially Equivalent

Minidam

Delsan Dental Systems, Pennington NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921117 is the FDA 510(k) clearance record for MINIDAM, a class I device, cleared for Delsan Dental Systems on under FDA product code DYN (Mouthpiece, Saliva Ejector). FDA records list 2 510(k) clearances for Delsan Dental Systems, from to . As of , FDA records show no recalls naming K921117.

Clearance record

Decision date
Received
(57 days to decision)
Product code
DYN Mouthpiece, Saliva Ejector
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Delsan Dental Systems 108 Howard Way, Pennington NJ
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