Cleared Traditional

K905321 - PLATINUM FOIL

K905321 is the FDA 510(k) clearance for PLATINUM FOIL by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905321 · Ivoclar North America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
90d
Days
Class 2
Risk

K905321 is an FDA 510(k) clearance for the PLATINUM FOIL, VARIOUS SIZES. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 90 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K905321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date February 26, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 275
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K905321.
VITA OMEGA PORCELAIN
K921474 · Vident · Jun 1992
NEW OPAQUE PORCELAIN
K915543 · Dentsply Intl. · Mar 1992
IPS EMPRESS
K913372 · Ivoclar North America, Inc. · Oct 1991
WILL-CERAM BRUSHES, SUPER BRUSH KIT
K905328 · Ivoclar North America, Inc. · Jan 1991
VMK 68 AND VMK 68N DENTAL PORCELAIN KIT
K901862 · Vident · Oct 1990
VITACHROM-L DENTAL PORCELAIN KIT
K901982 · Vident · Oct 1990