Cleared Traditional

K810959 - SECURE

K810959 is an FDA 510(k) clearance for SECURE, manufactured by Sci-Pharm, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810959 · Sci-Pharm, Inc. · Dental device
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Apr 1981
Decision
13d
Days
Class 2
Risk

K810959 is an FDA 510(k) clearance for the SECURE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Sci-Pharm, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1981 after a review of 13 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 Sci-Pharm, Inc. devices

FDA 510(k) Submission Details - K810959

510(k) Number K810959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1981
Decision Date April 21, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
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 151
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K810959.
TOOTH CONDITIONER
K823928 · Dentsply Intl. · Jan 1983
HELIOSIT-ORTHODONTIC
K823409 · Vivadent (Usa), Inc. · Jan 1983
ORTHODAPTIC* BONDING ADHESIVE
K823851 · Johnson & Johnson Professionals, Inc. · Jan 1983
INSTA-BOND
K810517 · Lee Pharmaceuticals · Mar 1981
SCI-PHARM ORTHODONTIC ADHESIVE
K791132 · Scientific Pharmaceuticals, Inc. · Aug 1979
SEAL & BOND DIRECT BONDING ORTHODONTIC
K790962 · Scientific Pharmaceuticals, Inc. · Jul 1979