Cleared Traditional

FINESSE PORCELAIN SYSTEM (K940252) - FDA 510(k) Clearance

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

K940252 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
39d
Days
Class 2
Risk

K940252 is an FDA 510(k) clearance for the FINESSE PORCELAIN SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 39 days - a notably fast clearance cycle.

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: 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 Dentsply Intl. devices

Submission Details

510(k) Number K940252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date March 01, 1994
Days to Decision 39 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
88d faster than avg
Panel avg: 127d · This submission: 39d
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 164
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K940252.
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
K961291 · Dentsply Intl. · May 1996
FINESSE LOW-FUSING PORCELAIN SYSTEM
K954761 · Dentsply Intl. · Nov 1995
SOFTWEAR PORCELAIN SYSTEM
K943582 · Dentsply Intl. · Aug 1994
DENTAL PORCELAIN
K921619 · Dentsply Intl. · Jul 1992
NEW OPAQUE PORCELAIN
K915543 · Dentsply Intl. · Mar 1992
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990