Cleared Traditional

K000597 - VITA RESPONSE

K000597 is an FDA 510(k) clearance for VITA RESPONSE, manufactured by Vident. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K000597 · Vident · Dental device
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May 2000
Decision
85d
Days
Class 2
Risk

K000597 is an FDA 510(k) clearance for the VITA RESPONSE. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vident (Brea, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vident devices

FDA 510(k) Submission Details - K000597

510(k) Number K000597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date May 17, 2000
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
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 K000597.
HERACERAM
K002993 · J.F. Jelenko & Co., Inc. · Nov 2000
WILLI GELLER CREATION AND LF PORCELAIN
K002904 · Jensen Industries, Inc. · Nov 2000
WILLI GELLER CREATION & AV PORCELAIN
K002041 · Jensen Industries, Inc. · Aug 2000
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
K994435 · Jeneric/Pentron, Inc. · Feb 2000
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
CERGOGOLD
K993897 · Degussa - Ney Dental, Inc. · Jan 2000