Cleared Traditional

K971121 - ENCORE BOND

K971121 is the FDA 510(k) clearance for ENCORE BOND by Centrix, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K971121 · Centrix, Inc. · Dental device
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Jun 1997
Decision
92d
Days
Class 2
Risk

K971121 is an FDA 510(k) clearance for the ENCORE BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 92 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 Centrix, Inc. devices

Submission Details

510(k) Number K971121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1997
Decision Date June 27, 1997
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 282
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K971121.
DENTIN CONDITIONING AND ADHESIVE (BOND 1)
K973388 · Jeneric/Pentron, Inc. · Sep 1997
EASY BOND
K972421 · Parkell, Inc. · Aug 1997
METALPRIMER II
K972594 · GC America, Inc. · Aug 1997
SILOC SYSTEM
K970848 · Heraeus Kulzer, Inc. · May 1997
HYBRID RESIN COMPOSITE
K964867 · Parkell, Inc. · Apr 1997
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
K964038 · Heraeus Kulzer, Inc. · Apr 1997