Cleared Traditional

K931710 - PULPDENT DENTAL BOND ENHANCER 2-B

K931710 is an FDA 510(k) clearance for PULPDENT DENTAL BOND ENHANCER 2-B, manufactured by Pulpdent Corp.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K931710 · Pulpdent Corp. · Dental device
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Aug 1993
Decision
140d
Days
Class 2
Risk

K931710 is an FDA 510(k) clearance for the PULPDENT DENTAL BOND ENHANCER 2-B. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 140 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 Pulpdent Corp. devices

FDA 510(k) Submission Details - K931710

510(k) Number K931710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date August 24, 1993
Days to Decision 140 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
13d slower than avg
Panel avg: 127d · This submission: 140d
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 380
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K931710.
ATTACHMENT BOND
K935735 · Heraeus Kulzer, Inc. · Mar 1994
BISCO DUO LINK D/C LUTING COMPOSITE
K934596 · Bisco, Inc. · Jan 1994
KERR OPTIBOND, MODIFICATION
K934690 · Kerr Corporation (Danbury) · Dec 1993
BONDING RESIN PRODUCT LINE
K931870 · Ultradent Products, Inc. · Jul 1993
ALL-BOND(R) JR.
K932379 · Bisco, Inc. · Jul 1993
NEW DENTINE ADHESIVE
K931812 · Dentsply Intl. · Jul 1993