Cleared Traditional

K034017 - JEJE TEETHER

K034017 is an FDA 510(k) clearance for JEJE TEETHER, manufactured by Vibe 2000. The device is a Class 1 Dental device with product code MEF cleared through the Traditional 510(k) pathway after a 299-day FDA review.

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

FDA 510(k) Submission Details - K034017

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.

MEF Device Classification - Class 1, General Controls

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.