Cleared Traditional

JELDENT BASIC LINE (K000213) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000213 · J.F. Jelenko & Co. · Dental device
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Apr 2000
Decision
73d
Days
Class 2
Risk

K000213 is an FDA 510(k) clearance for the JELDENT BASIC LINE. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by J.F. Jelenko & Co. (Armonk, US). The FDA issued a Cleared decision on April 6, 2000 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all J.F. Jelenko & Co. devices

Submission Details

510(k) Number K000213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2000
Decision Date April 06, 2000
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.