Cleared Traditional

K934195 - VITA CELAY BLANKS AND VITA CELAY OPTIMIZER

K934195 is the FDA 510(k) clearance for VITA CELAY BLANKS AND VITA CELAY OPTIMIZER by Vident. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K934195 · Vident · Dental device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
204d
Days
Class 2
Risk

K934195 is an FDA 510(k) clearance for the VITA CELAY BLANKS AND VITA CELAY OPTIMIZER. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on March 18, 1994 after a review of 204 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 K934195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date March 18, 1994
Days to Decision 204 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 127d · This submission: 204d
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 276
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K934195.
IN-CERAM SPINELL
K951183 · Vident · May 1995
PROCERA ALL-CERAMIC PORCELAIN
K944702 · Nobelpharma USA, Inc. · Dec 1994
SOFTWEAR PORCELAIN SYSTEM
K943582 · Dentsply Intl. · Aug 1994
FINESSE PORCELAIN SYSTEM
K940252 · Dentsply Intl. · Mar 1994
G-CERA ORBIT COLOUR COMMUNICATION SET
K932039 · GC America, Inc. · Jul 1993
BISCO PORCELAIN ETCHING GEL
K926238 · Bisco, Inc. · Mar 1993