Cleared Traditional

K973542 - MASKY

K973542 is an FDA 510(k) clearance for MASKY, manufactured by Pressing DI Monticelli Rag. Stefano. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K973542 · Pressing DI Monticelli Rag. Stefano · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
145d
Days
Class 2
Risk

K973542 is an FDA 510(k) clearance for the MASKY. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Pressing DI Monticelli Rag. Stefano (Corvallis, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Pressing DI Monticelli Rag. Stefano devices

FDA 510(k) Submission Details - K973542

510(k) Number K973542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1997
Decision Date February 10, 1998
Days to Decision 145 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
18d slower than avg
Panel avg: 127d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 219
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K973542.
CSR
K974865 · Parkell, Inc. · Mar 1998
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K974160 · Bruxcare, LLC · Mar 1998
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K974727 · J.B.C and Co. · Feb 1998
UFI GEL C
K974772 · Voco GmbH · Feb 1998
LANG DENTAL RESIN A97 FIBRED PINK
K972553 · Lang Dental Mfg. Co., Inc. · Nov 1997
LIQCRYLIC PRO DENTAL RESIN
K972573 · Dentsply Intl. · Sep 1997