510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061351Substantially Equivalent

Oral-B Sonic Complete

Braun GmbH, Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061351 is the FDA 510(k) clearance record for ORAL-B SONIC COMPLETE, a class I device, cleared for Braun GmbH on under FDA product code JEQ (Toothbrush, Powered). FDA records list 3 510(k) clearances for Braun GmbH, from to . As of , FDA records show no recalls naming K061351.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JEQ Toothbrush, Powered
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Braun GmbH 800 Boylston St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEQ

Trailing 12 months

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

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