Cleared Traditional

KERAMAIL (K915653) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915653 · Wilde-USA, Inc. · Dental device
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Apr 1993
Decision
477d
Days
Class 2
Risk

K915653 is an FDA 510(k) clearance for the KERAMAIL. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Wilde-USA, Inc. (Chicago, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 477 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Wilde-USA, Inc. devices

Submission Details

510(k) Number K915653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date April 08, 1993
Days to Decision 477 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
350d slower than avg
Panel avg: 127d · This submission: 477d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 165
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K915653.
FINESSE LOW-FUSING PORCELAIN SYSTEM
K954761 · Dentsply Intl. · Nov 1995
SOFTWEAR PORCELAIN SYSTEM
K943582 · Dentsply Intl. · Aug 1994
FINESSE PORCELAIN SYSTEM
K940252 · Dentsply Intl. · Mar 1994
DENTAL PORCELAIN
K921619 · Dentsply Intl. · Jul 1992
NEW OPAQUE PORCELAIN
K915543 · Dentsply Intl. · Mar 1992
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990