510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885189Substantially Equivalent

Massaging Pick for Oral Hygiene

Dentek Corp., Novato CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885189 is the FDA 510(k) clearance record for MASSAGING PICK FOR ORAL HYGIENE, a class I device, cleared for Dentek Corp. on under FDA product code JET (Pick, Massaging). FDA records list one 510(k) clearance for Dentek Corp. As of , FDA records show no recalls naming K885189.

Clearance record

Decision date
Received
(91 days to decision)
Product code
JET Pick, Massaging
Regulation
21 CFR 872.6650
Device class
Class I
Review panel
Dental
Applicant
Dentek Corp. 32 Leveroni Ct., Novato CA
Third party review
No

Clearances, product code JET

Trailing 12 months

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

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