Cleared Traditional

K000213 - JELDENT BASIC LINE

K000213 is an FDA 510(k) clearance for JELDENT BASIC LINE, manufactured by J.F. Jelenko & Co.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 73-day FDA review.

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

FDA 510(k) Submission Details - K000213

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.

ELM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ELM Denture, Plastic, Teeth

All 28
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K000213.
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · Ivoclar Vivadent, Inc. · Dec 2002
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
WILLI GELLER CREAPEARL
K010160 · Jensen Industries, Inc. · Mar 2001
ARTIFICIAL TEETH (ACRYLIC TEETH)
K992854 · Masterdent Ltda. · Feb 2000
NATURA DENTURE TEETH
K984134 · Davis Schottlander & Davis, Ltd. · Feb 1999
ENIGMA DENTURE TEETH
K984128 · Davis Schottlander & Davis, Ltd. · Feb 1999