Cleared Traditional

K161077 - RnD TE and RnD SE

K161077 is an FDA 510(k) clearance for RnD TE and RnD SE, manufactured by Apex Dental Materials, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K161077 · Apex Dental Materials, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
333d
Days
Class 2
Risk

K161077 is an FDA 510(k) clearance for the RnD TE and RnD SE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on March 17, 2017 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Apex Dental Materials, Inc. devices

FDA 510(k) Submission Details - K161077

510(k) Number K161077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2016
Decision Date March 17, 2017
Days to Decision 333 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
206d slower than avg
Panel avg: 127d · This submission: 333d
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 371
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K161077.
TOKUYAMA UNIVERSAL BOND
K171226 · Tokuyama Dental Corporation · Nov 2017
Parkell Universal Adhesive
K172176 · Parkell, Inc. · Nov 2017
SHOFU MZ Primer Plus
K172106 · Shofu Dental Corporation · Aug 2017
HC Primer
K161891 · Shofu Dental Corporation · Nov 2016
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
K161042 · Kuraray Noritake Dental, Inc. · Oct 2016
All-Bond Universal w/BAC (not finalized)
K161051 · Bisco, Inc. · Sep 2016