Cleared Traditional

PRISMA III (K832320) - FDA 510(k) Clearance

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

K832320 · Dentsply Intl. · Dental device
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Aug 1983
Decision
47d
Days
Class 2
Risk

K832320 is an FDA 510(k) clearance for the PRISMA III. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 47 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 Dentsply Intl. devices

Submission Details

510(k) Number K832320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1983
Decision Date August 31, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K832320.
ORTHOLUX XT
K930086 · 3M Company · Apr 1993
3M CURING LIGHT XL 3000
K924812 · 3M Company · Nov 1992
PHOTO-CURING LIGHT
K882145 · Dentsply Intl. · Sep 1988
CAULK PRISMA-LITE
K801588 · Dentsply Intl. · Sep 1980
FOTOFILL ACTIVATOR LIGHT
K772278 · Johnson & Johnson Professionals, Inc. · Jan 1978
NUVA-LITE II PHOTO-CURE UNIT
K770599 · Dentsply Intl. · Apr 1977