Cleared Traditional

K934611 - STO2P

K934611 is the FDA 510(k) clearance for STO2P by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K934611 · Ivoclar North America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
51d
Days
Class 2
Risk

K934611 is an FDA 510(k) clearance for the STO2P. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on November 17, 1993 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K934611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1993
Decision Date November 17, 1993
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K934611.
MAGNACORE
K930584 · Scientific Pharmaceuticals, Inc. · Feb 1994
CHARISMA SUPERLIGHT
K935736 · Heraeus Kulzer, Inc. · Jan 1994
BISCO UNIVERSAL HYBRID COMPOSITE
K934247 · Bisco, Inc. · Nov 1993
SR SPECTRASIT, SR CHROMASIT
K930128 · Ivoclar North America, Inc. · Oct 1993
ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE
K932886 · Wallace A. Erickson & Co. · Sep 1993
CONQUEST CRYSTAL
K932154 · Jeneric/Pentron, Inc. · Sep 1993