510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070127Substantially Equivalent

Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02

Kevin Vu, Dds, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070127 is the FDA 510(k) clearance record for PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02, a class I device, cleared for Kevin Vu, Dds on under FDA product code EMN (Scaler, Periodontic). FDA records list one 510(k) clearance for Kevin Vu, Dds. As of , FDA records show no recalls naming K070127.

Clearance record

Decision date
Received
(72 days to decision)
Product code
EMN Scaler, Periodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Kevin Vu, Dds 1340 W Pennsylvania Ave., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EMN

Trailing 12 months

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

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