Cleared Traditional

VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A (K930835) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930835 · Ivoclar North America, Inc. · Dental device
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Jul 1994
Decision
520d
Days
Class 2
Risk

K930835 is an FDA 510(k) clearance for the VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on July 22, 1994 after a review of 520 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K930835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date July 22, 1994
Days to Decision 520 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
393d slower than avg
Panel avg: 127d · This submission: 520d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 8
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K930835.
Additive Manufacturing Zirconia Customized Restoration
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Franz Zirconia Dental Crown
K203072 · Franz Biotech, Inc. · Jan 2022
ARGI-SATIN OR OPTI0-STAR
K965216 · Argen Precious Metals, Inc. · Feb 1997
SPECTRUM
K880774 · Dentsply Intl. · May 1988
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608 · Dentsply Intl. · Mar 1986