Cleared Traditional

K925027 - PHOTAC-FIL APLICAP

K925027 is an FDA 510(k) clearance for PHOTAC-FIL APLICAP, manufactured by Espe GmbH (Us). The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K925027 · Espe GmbH (Us) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
259d
Days
Class 2
Risk

K925027 is an FDA 510(k) clearance for the PHOTAC-FIL APLICAP. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Espe GmbH (Us) (West Germany, DE). The FDA issued a Cleared decision on June 18, 1993 after a review of 259 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Espe GmbH (Us) devices

FDA 510(k) Submission Details - K925027

510(k) Number K925027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date June 18, 1993
Days to Decision 259 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
132d slower than avg
Panel avg: 127d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K925027.
FASTFIL
K934184 · Scientific Pharmaceuticals, Inc. · Dec 1993
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K924132 · Cosmedent, Inc. · Jul 1993
VARIGLASS VLC GLASS IONOMER
K931229 · Dentsply Intl. · Jul 1993
LCL 8
K930116 · Voco GmbH · Jun 1993
TEMPIT
K931084 · Centrix, Inc. · May 1993
MULTIPURPOSE RESIN CEMENT
K923473 · Dentsply Intl. · Apr 1993