Cleared Traditional

K895901 - VITA CEREC SET AND VITA CEREC BLOCS

K895901 is the FDA 510(k) clearance for VITA CEREC SET AND VITA CEREC BLOCS by Vident. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 833-day FDA review.

K895901 · Vident · Dental device
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Jan 1992
Decision
833d
Days
Class 2
Risk

K895901 is an FDA 510(k) clearance for the VITA CEREC SET AND VITA CEREC BLOCS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 833 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

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Submission Details

510(k) Number K895901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1989
Decision Date January 17, 1992
Days to Decision 833 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
706d slower than avg
Panel avg: 127d · This submission: 833d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K895901.
TRIANGULAR JAW MICROLARYNGEAL FORCEPS
K925370 · Pilling Co. · Mar 1993
Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL
K923202 · Jeneric/Pentron, Inc. · Aug 1992
CORRECTED-V.P.S.
K914178 · Jeneric/Pentron, Inc. · Apr 1992
CORRECT-S.I.M.
K914437 · Jeneric/Pentron, Inc. · Jan 1992
MEMOSIL C.D.
K913537 · Heraeus Kulzer, Inc. · Oct 1991
CUTTERSIL MUCOSA
K910165 · Heraeus Kulzer, Inc. · Jun 1991