Cleared Traditional

K921619 - DENTAL PORCELAIN

K921619 is the FDA 510(k) clearance for DENTAL PORCELAIN by Dentsply Intl.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K921619 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
87d
Days
Class 2
Risk

K921619 is an FDA 510(k) clearance for the DENTAL PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on July 2, 1992 after a review of 87 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 K921619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date July 02, 1992
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 277
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K921619.
G-CERA ORBIT COLOUR COMMUNICATION SET
K932039 · GC America, Inc. · Jul 1993
BISCO PORCELAIN ETCHING GEL
K926238 · Bisco, Inc. · Mar 1993
JELENKO PORCELAIN SYSTEM PVS PROCELAIN
K923717 · J.F. Jelenko & Co., Inc. · Mar 1993
VITADUR ALPHA PORCELAIN
K921623 · Vident · Jul 1992
VITA IN-CERAM
K913644 · Vident · Jun 1992
DUCERATIN/DUCERAM LFC DENTAL PORCELAIN
K921479 · Degussa AG · Jun 1992