Cleared Traditional

K014138 - PULPDENT TRIPLE-CURE REINFORCED GLASS I...

K014138 is the FDA 510(k) clearance for PULPDENT TRIPLE-CURE REINFORCED GLASS I... by Pulpdent Corp.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K014138 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
87d
Days
Class 2
Risk

K014138 is an FDA 510(k) clearance for the PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT. 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 March 14, 2002 after a review of 87 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 K014138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2001
Decision Date March 14, 2002
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 K014138.
SOLO ORTHO 3
K020502 · Sybron Dental Specialties, Inc. · May 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · GC America, Inc. · Apr 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · Pulpdent Corp. · Mar 2002
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · Pulpdent Corp. · Feb 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · Pulpdent Corp. · Feb 2002
FIRST SPEP
K012032 · Bisco, Inc. · Sep 2001