Cleared Traditional

K020115 - PULPDENT SEALANT/PASTE ORTHODONTIC BRAC...

K020115 is the FDA 510(k) clearance for PULPDENT SEALANT/PASTE ORTHODONTIC BRAC... by Pulpdent Corp.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K020115 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
48d
Days
Class 2
Risk

K020115 is an FDA 510(k) clearance for the PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on February 28, 2002 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 K020115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2002
Decision Date February 28, 2002
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 115
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K020115.
GC FUJI ORTHO BAND PASTE PAK
K020578 · GC America, Inc. · Apr 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · Pulpdent Corp. · Mar 2002
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K014138 · Pulpdent Corp. · Mar 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · Pulpdent Corp. · Feb 2002
FIRST SPEP
K012032 · Bisco, Inc. · Sep 2001
IMPROVED ENLIGHT LV
K001881 · Sybron Dental Specialties, Inc. · Aug 2000