Cleared Traditional

K803209 - ELIPAR LIGHT SOURCE

K803209 is an FDA 510(k) clearance for ELIPAR LIGHT SOURCE, manufactured by Espe-Premier Sales Co.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K803209 · Espe-Premier Sales Co. · Dental device
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Jan 1981
Decision
27d
Days
Class 2
Risk

K803209 is an FDA 510(k) clearance for the ELIPAR LIGHT SOURCE. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Espe-Premier Sales Co. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1981 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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 Espe-Premier Sales Co. devices

FDA 510(k) Submission Details - K803209

510(k) Number K803209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1980
Decision Date January 14, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 128d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 167
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K803209.
TRANSLUX CL
K843823 · Kulzer, Inc. · Dec 1984
PRISMA III
K832320 · Dentsply Intl. · Aug 1983
KULZER TRANSLUX VISIBLE LIGHT CURING
K811668 · Kulzer, Inc. · Jul 1981
CAULK PRISMA-LITE
K801588 · Dentsply Intl. · Sep 1980
FOTOFILL ACTIVATOR LIGHT
K772278 · Johnson & Johnson Professionals, Inc. · Jan 1978
ULTRAVIOLET RAD-EMITTING LAMP
K771077 · Lee Pharmaceuticals · Jun 1977