Cleared Traditional

K993683 - PULPDENT UNO-DUO

K993683 is the FDA 510(k) clearance for PULPDENT UNO-DUO by Pulpdent Corp.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K993683 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
42d
Days
Class 2
Risk

K993683 is an FDA 510(k) clearance for the PULPDENT UNO-DUO. 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 December 13, 1999 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pulpdent Corp. devices

Submission Details

510(k) Number K993683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date December 13, 1999
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 K993683.
KERR GEL ETCHANT
K000954 · Sybron Dental Specialties, Inc. · Apr 2000
BOND 1 C & B
K994359 · Jeneric/Pentron, Inc. · Mar 2000
RESIN TOOTH BONDING AGENT
K994302 · Parkell, Inc. · Feb 2000
GLUMA COMFORT BOND
K992985 · Heraeus Kulzer, Inc. · Oct 1999
GLUMA COMFORT BOND + DESENSITIZER
K992292 · Heraeus Kulzer, Inc. · Oct 1999
OPTIBOND SOLO PLUS 2
K991808 · Sybron Dental Specialties, Inc. · Jul 1999