510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864059Substantially Equivalent

Dental Prophy Cups (Various Types)

Mission White Dental, Inc., Tinton Falls NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864059 is the FDA 510(k) clearance record for DENTAL PROPHY CUPS (VARIOUS TYPES), a class I device, cleared for Mission White Dental, Inc. on under FDA product code EHK (Cup, Prophylaxis). FDA records list 2 510(k) clearances for Mission White Dental, Inc., from to . As of , FDA records show no recalls naming K864059.

Clearance record

Decision date
Received
(30 days to decision)
Product code
EHK Cup, Prophylaxis
Regulation
21 CFR 872.6290
Device class
Class I
Review panel
Dental
Applicant
Mission White Dental, Inc. 31 Park Rd., Tinton Falls NJ
Third party review
No

Clearances, product code EHK

Trailing 12 months

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

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