Cleared Traditional

K011022 - BIOUNIVERSAL PDF

K011022 is the FDA 510(k) clearance for BIOUNIVERSAL PDF by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K011022 · Ivoclar North America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
28d
Days
Class 2
Risk

K011022 is an FDA 510(k) clearance for the BIOUNIVERSAL PDF. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 28 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 North America, Inc. devices

Submission Details

510(k) Number K011022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2001
Decision Date May 02, 2001
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K011022.
JP CAST 40
K011331 · Jeneric/Pentron, Inc. · Jun 2001
GOLD CORE 73 LS
K011362 · Jeneric/Pentron, Inc. · May 2001
RD-3008
K011036 · Heraeus Kulzer, Inc. · May 2001
D.SIGN 96
K011023 · Ivoclar North America, Inc. · May 2001
COSMIC
K010044 · Jeneric/Pentron, Inc. · Feb 2001
DW 276 #3
K003635 · Ivoclar North America, Inc. · Dec 2000