Cleared Traditional

K971733 - 2 BOND 2

K971733 is an FDA 510(k) clearance for 2 BOND 2, 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 146-day FDA review.

K971733 · Heraeus Kulzer, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
146d
Days
Class 2
Risk

K971733 is an FDA 510(k) clearance for the 2 BOND 2. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on October 2, 1997 after a review of 146 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 - K971733

510(k) Number K971733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1997
Decision Date October 02, 1997
Days to Decision 146 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
19d slower than avg
Panel avg: 127d · This submission: 146d
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 382
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K971733.
STAE
K973092 · Southern Dental Industries, Inc. · Dec 1997
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
K973185 · American Dental Products, Inc. · Nov 1997
TOKUSO REBASE MR. BOND
K973245 · Tokuyama America, Inc. · Oct 1997
SOLITAIRE
K972101 · Heraeus Kulzer, Inc. · Sep 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