Cleared Traditional

K934195 - VITA CELAY BLANKS AND VITA CELAY OPTIMIZER

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

K934195 · Vident · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K934195

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.

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 430
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