Cleared Traditional

K911286 - PULPDENT ORTHODONTIC BRACKET ADHESIVE

K911286 is an FDA 510(k) clearance for PULPDENT ORTHODONTIC BRACKET ADHESIVE, manufactured by Pulpdent Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K911286

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.

DYH Device Classification - Class 2, Special Controls

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 146
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
ADHESIVE PRECOATED BRACKETS
K911271 · Unitek Corp. · May 1991
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