Cleared Traditional

SOLITAIRE 2 (K993932) - FDA 510(k) Clearance

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

K993932 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
34d
Days
Class 2
Risk

K993932 is an FDA 510(k) clearance for the SOLITAIRE 2. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 22, 1999 after a review of 34 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K993932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1999
Decision Date December 22, 1999
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
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 208
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K993932.
VENUS FLOW
K033665 · Heraeus Kulzer, Inc. · Dec 2003
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · Heraeus Kulzer, Inc. · Feb 2002
3M ESPE HAUR
K010781 · 3M Company · Apr 2001
PRE-VISION FILL
K993602 · Heraeus Kulzer, Inc. · Dec 1999
3M LVR SYSTEM
K991961 · 3M Company · Aug 1999
FLOW LINE
K990756 · Heraeus Kulzer, Inc. · May 1999