Cleared Traditional

K901261 - PV-CERAMIC, CERAMINIQUE

K901261 is an FDA 510(k) clearance for PV-CERAMIC, manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K901261 · Ivoclar North America, Inc. · Dental device
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Jun 1990
Decision
103d
Days
Class 2
Risk

K901261 is an FDA 510(k) clearance for the PV-CERAMIC, CERAMINIQUE. 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 June 26, 1990 after a review of 103 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

FDA 510(k) Submission Details - K901261

510(k) Number K901261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1990
Decision Date June 26, 1990
Days to Decision 103 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
24d faster than avg
Panel avg: 127d · This submission: 103d
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 421
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K901261.
VITADUR-N DENTAL PORCELAIN KIT
K902105 · Vident · Oct 1990
VITA HI-CERAM
K902200 · Vident · Oct 1990
DEN-MAT CERINATE PORCELAIN
K895731 · Den-Mat Corp. · Aug 1990
OPAQUE PORCELAIN
K900393 · Dentsply Intl. · Apr 1990
SILHOUETTE PORCELAIN
K895888 · Leach and Dillon Co., Inc. · Apr 1990
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K895889 · Leach and Dillon Co., Inc. · Apr 1990