Cleared Traditional

K971869 - FINESSE ALL-CERAMIC SYSTEM

K971869 is an FDA 510(k) clearance for FINESSE ALL-CERAMIC SYSTEM, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K971869 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
113d
Days
Class 2
Risk

K971869 is an FDA 510(k) clearance for the FINESSE ALL-CERAMIC 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 September 11, 1997 after a review of 113 days - within the typical 510(k) review window.

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: 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K971869

510(k) Number K971869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1997
Decision Date September 11, 1997
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 431
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K971869.
SONICSYS INLAY
K972648 · Ivoclar North America, Inc. · Oct 1997
VINTAGE HALO
K973247 · Shofu Dental Corp. · Oct 1997
IPS EMPRESS COSMO INGOT
K972827 · Ivoclar North America, Inc. · Sep 1997
SLIPPERY GLASS
K970941 · Jeneric/Pentron, Inc. · Apr 1997
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
K961291 · Dentsply Intl. · May 1996
FINESSE LOW-FUSING PORCELAIN SYSTEM
K954761 · Dentsply Intl. · Nov 1995