Cleared Traditional

K972101 - SOLITAIRE

K972101 is an FDA 510(k) clearance for SOLITAIRE, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K972101 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
117d
Days
Class 2
Risk

K972101 is an FDA 510(k) clearance for the SOLITAIRE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on September 29, 1997 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K972101

510(k) Number K972101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1997
Decision Date September 29, 1997
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K972101.
PQ 1
K974283 · Ultradent Products, Inc. · Jan 1998
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
K973185 · American Dental Products, Inc. · Nov 1997
2 BOND 2
K971733 · Heraeus Kulzer, Inc. · Oct 1997
KERR NEXUS ONE BOTTLE ADHESIVE
K972858 · Sybron Dental Specialties, Inc. · Sep 1997
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
K973388 · Jeneric/Pentron, Inc. · Sep 1997
EASY BOND
K972421 · Parkell, Inc. · Aug 1997