Cleared Traditional

FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS (K961291) - FDA 510(k) Clearance

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

K961291 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
54d
Days
Class 2
Risk

K961291 is an FDA 510(k) clearance for the FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on May 28, 1996 after a review of 54 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 K961291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date May 28, 1996
Days to Decision 54 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
73d faster than avg
Panel avg: 127d · This submission: 54d
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 K961291.
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
FINESSE ALL-CERAMIC SYSTEM
K971869 · Dentsply Intl. · Sep 1997
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