Cleared Traditional

K982318 - SPECTRUM 800 CURING UNIT

K982318 is the FDA 510(k) clearance for SPECTRUM 800 CURING UNIT by Dentsply Intl.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K982318 · Dentsply Intl. · Dental device

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Optimized for regulatory review, auditing and printing

Sep 1998

Decision

75d

Days

Class 2

Risk

K982318 is an FDA 510(k) clearance for the SPECTRUM 800 CURING UNIT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Dentsply Intl. devices

Submission Details

510(k) Number	K982318 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 02, 1998
Decision Date	September 15, 1998
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

52d faster than avg

Panel avg: 127d · This submission: 75d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	EBF Material, Tooth Shade, Resin
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 872.3690

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 - EBF Material, Tooth Shade, Resin

All 588

Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K982318.

R-30 AESTHETIC RESTORATIVE

K984387 · Dentsply Intl. · Jan 1999

ADVENT

K984112 · Bisco, Inc. · Dec 1998

PRODIGY- 3

K983370 · Sybron Dental Specialties, Inc. · Nov 1998

RENEW

K982729 · Bisco, Inc. · Sep 1998

PYRAMID

K982645 · Bisco, Inc. · Sep 1998

DYTRACT FLOW RESTORATIVE

K982395 · Dentsply Intl. · Aug 1998

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K982318

Dentsply Intl.

York, PA · US

P. JEFFERY LEHN

Regulatory profile

279 submissions 279 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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