510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K034017Substantially Equivalent

Jeje Teether

Vibe 2000, Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K034017 is the FDA 510(k) clearance record for JEJE TEETHER, a class I device, cleared for Vibe 2000 on under FDA product code MEF (Ring, Teething, Non-Fluid Filled). FDA records list one 510(k) clearance for Vibe 2000. As of , FDA records show no recalls naming K034017.

Clearance record

Decision date
Received
(299 days to decision)
Product code
MEF Ring, Teething, Non-Fluid Filled
Regulation
21 CFR 872.5550
Device class
Class I
Review panel
Dental
Applicant
Vibe 2000 21911 Erie Ln., Lake Forest CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEF

Trailing 12 months

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

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