Cleared Traditional

K030436 - BIO UNIVERSAL

K030436 is the FDA 510(k) clearance for BIO UNIVERSAL by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K030436 · Ivoclar Vivadent, Inc. · Dental device
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Apr 2003
Decision
64d
Days
Class 2
Risk

K030436 is an FDA 510(k) clearance for the BIO UNIVERSAL. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on April 15, 2003 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K030436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2003
Decision Date April 15, 2003
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 377
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K030436.
ALEXANDER
K032493 · Ivoclar Vivadent, Inc. · Sep 2003
PORTA PRESSOVER
K031264 · Wieland Dental + Technik GmbH & Co. KG · Jun 2003
BIOUNIVERSAL PKF
K030435 · Ivoclar Vivadent, Inc. · Apr 2003
PORTA IMPLANT
K030312 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
PORTADUR P2
K023395 · Wieland Dental + Technik GmbH & Co. KG · Dec 2002
BIOPORTA G
K023391 · Wieland Dental + Technik GmbH & Co. KG · Dec 2002