510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000140Substantially Equivalent

Clini-Dent

The Precident Group, Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000140 is the FDA 510(k) clearance record for CLINI-DENT, a class I device, cleared for The Precident Group on under FDA product code MAU (Eraser, Dental Stain). FDA records list one 510(k) clearance for The Precident Group. As of , FDA records show no recalls naming K000140.

Clearance record

Decision date
Received
(106 days to decision)
Product code
MAU Eraser, Dental Stain
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
The Precident Group 200 Westpark Corporate Center, Durham NC
510(k) summary
Summary
Third party review
No

Clearances, product code MAU

Trailing 12 months

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

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