Cleared Traditional

K901982 - VITACHROM-L DENTAL PORCELAIN KIT

K901982 is the FDA 510(k) clearance for VITACHROM-L DENTAL PORCELAIN KIT by Vident. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K901982 · Vident · Dental device
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Oct 1990
Decision
156d
Days
Class 2
Risk

K901982 is an FDA 510(k) clearance for the VITACHROM-L DENTAL PORCELAIN KIT. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on October 5, 1990 after a review of 156 days - an extended review 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: 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 Vident devices

Submission Details

510(k) Number K901982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date October 05, 1990
Days to Decision 156 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
29d slower than avg
Panel avg: 127d · This submission: 156d
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 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K901982.
PLATINUM FOIL, VARIOUS SIZES
K905321 · Ivoclar North America, Inc. · Feb 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
VITADUR-N DENTAL PORCELAIN KIT
K902105 · Vident · Oct 1990
VITA HI-CERAM
K902200 · Vident · Oct 1990
PV-CERAMIC, CERAMINIQUE
K901261 · Ivoclar North America, Inc. · Jun 1990