Cleared Traditional

JEJE TEETHER (K034017) - FDA 510(k) Clearance

Class I Dental device.

K034017 · Vibe 2000 · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
299d
Days
Class 1
Risk

K034017 is an FDA 510(k) clearance for the JEJE TEETHER. Classified as Ring, Teething, Non-fluid Filled (product code MEF), Class I - General Controls.

Submitted by Vibe 2000 (Lake Forest, US). The FDA issued a Cleared decision on October 18, 2004 after a review of 299 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5550 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Vibe 2000 devices

Submission Details

510(k) Number K034017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date October 18, 2004
Days to Decision 299 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 127d · This submission: 299d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MEF Ring, Teething, Non-fluid Filled
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.