Cleared Traditional

K901862 - VMK 68 AND VMK 68N DENTAL PORCELAIN KIT

K901862 is an FDA 510(k) clearance for VMK 68 AND VMK 68N DENTAL PORCELAIN KIT, manufactured by Vident. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K901862 · Vident · Dental device
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Oct 1990
Decision
169d
Days
Class 2
Risk

K901862 is an FDA 510(k) clearance for the VMK 68 AND VMK 68N 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 10, 1990 after a review of 169 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

FDA 510(k) Submission Details - K901862

510(k) Number K901862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date October 10, 1990
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
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 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K901862.
IPS EMPRESS
K913372 · Ivoclar North America, Inc. · Oct 1991
PLATINUM FOIL, VARIOUS SIZES
K905321 · Ivoclar North America, Inc. · Feb 1991
WILL-CERAM BRUSHES, SUPER BRUSH KIT
K905328 · Ivoclar North America, Inc. · Jan 1991
VITACHROM-L DENTAL PORCELAIN KIT
K901982 · Vident · Oct 1990
VITADUR-N DENTAL PORCELAIN KIT
K902105 · Vident · Oct 1990
VITA HI-CERAM
K902200 · Vident · Oct 1990