Cleared Traditional

K962442 - HYTAC APLITIP/HYTAC OSB

K962442 is an FDA 510(k) clearance for HYTAC APLITIP/HYTAC OSB, manufactured by Espe GmbH & Co. Kg.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K962442 · Espe GmbH & Co. Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
79d
Days
Class 2
Risk

K962442 is an FDA 510(k) clearance for the HYTAC APLITIP/HYTAC OSB. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Espe GmbH & Co. Kg. (Seefeld, DE). The FDA issued a Cleared decision on September 11, 1996 after a review of 79 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 Espe GmbH & Co. Kg. devices

FDA 510(k) Submission Details - K962442

510(k) Number K962442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1996
Decision Date September 11, 1996
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 708
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K962442.
TEAM ETCH
K963311 · Centrix, Inc. · Oct 1996
TARGIS SYSTEM
K962878 · Ivoclar North America, Inc. · Sep 1996
PERTAC II/PERTAC II APLITIP
K962440 · Espe GmbH & Co. Kg. · Sep 1996
SUNRISE CURING LAMP
K962192 · Sunrise Technologies, Inc. · Sep 1996
VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM
K961434 · Vident · Jul 1996
CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE
K960667 · Wallace A. Erickson & Co. · Jul 1996