Cleared Traditional

K915005 - PHOTAC-BOND APLICAP, MODIFICATION

K915005 is an FDA 510(k) clearance for PHOTAC-BOND 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 68-day FDA review.

K915005 · Espe GmbH (Us) · Dental device
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Jan 1992
Decision
68d
Days
Class 2
Risk

K915005 is an FDA 510(k) clearance for the PHOTAC-BOND APLICAP, MODIFICATION. 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 January 14, 1992 after a review of 68 days - a notably fast clearance 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: 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

FDA 510(k) Submission Details - K915005

510(k) Number K915005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1991
Decision Date January 14, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
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 K915005.
IONOFIL/LONOFIL MOLAR
K915619 · Voco GmbH · Feb 1992
MERON DENTAL CEMENT
K914612 · Voco GmbH · Feb 1992
CIMPAT S DENTAL CEMENT
K915467 · Specialites Septodont · Feb 1992
CAVITY VARNISH PRODUCT
K914324 · Confi-Dental Products Co. · Dec 1991
FUJI II LC
K913884 · G-C Intl. Corp. · Oct 1991
F21(R) DENTAL CEMENT
K914073 · Voco GmbH · Oct 1991