Cleared Traditional

K911286 - PULPDENT ORTHODONTIC BRACKET ADHESIVE

K911286 is the FDA 510(k) clearance for PULPDENT ORTHODONTIC BRACKET ADHESIVE by Pulpdent Corp.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K911286 · Pulpdent Corp. · Dental device
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Jul 1991
Decision
108d
Days
Class 2
Risk

K911286 is an FDA 510(k) clearance for the PULPDENT ORTHODONTIC BRACKET ADHESIVE. 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 July 5, 1991 after a review of 108 days - within the typical 510(k) review window.

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: 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

Submission Details

510(k) Number K911286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date July 05, 1991
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 127d · This submission: 108d
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 K911286.
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
K914317 · Confi-Dental Products Co. · Mar 1992
PORCELAIN PRIMER
K920534 · Confi-Dental Products Co. · Mar 1992
SEQUENCE LIGHT CURE ADHESIVE
K914727 · Ormco Corp. · Jan 1992
PHASE II ORTHODONTIC ADHESIVE
K895523 · Reliance Orthodontic Products, Inc. · Dec 1989
RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)
K895521 · Reliance Orthodontic Products, Inc. · Dec 1989
LIGHT BOND PASTE W/FLUORIDE
K895522 · Reliance Orthodontic Products, Inc. · Dec 1989