Cleared Traditional

K904097 - PHOTAC-BOND APLICAP

K904097 is the FDA 510(k) clearance for PHOTAC-BOND APLICAP by Espe GmbH (Us). It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K904097 · Espe GmbH (Us) · Dental device
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Nov 1990
Decision
64d
Days
Class 2
Risk

K904097 is an FDA 510(k) clearance for the PHOTAC-BOND APLICAP. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on November 9, 1990 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 GmbH (Us) devices

Submission Details

510(k) Number K904097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date November 09, 1990
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 47
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K904097.
IONOSEAL
K912495 · Voco GmbH · Jul 1991
VLC GLASS IONOMER LINER
K911244 · Dentsply Intl. · Jun 1991
PHOTAC-BOND
K904096 · Espe GmbH (Us) · Nov 1990
INTERFACE - CAVITY LINER
K897130 · Scientific Pharmaceuticals, Inc. · Mar 1990
BASIC CALCIUM HYDROXIDE LINER
K896529 · Ivoclar North America, Inc. · Jan 1990
GLASS IONOMER BASE
K882751 · Dentsply Intl. · Nov 1988