Cleared Traditional

K790962 - SEAL & BOND DIRECT BONDING ORTHODONTIC

K790962 is an FDA 510(k) clearance for SEAL & BOND DIRECT BONDING ORTHODONTIC, manufactured by Scientific Pharmaceuticals, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K790962 · Scientific Pharmaceuticals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1979
Decision
45d
Days
Class 2
Risk

K790962 is an FDA 510(k) clearance for the SEAL & BOND DIRECT BONDING ORTHODONTIC. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1979 after a review of 45 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 Scientific Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K790962

510(k) Number K790962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1979
Decision Date July 06, 1979
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
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 K790962.
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
ORTHODONTIC. PLASTIC BRACKET PRIMER
K780028 · 3M Company · Jan 1978
TEMP. BRIDGE, POSTERIOR 3-UNIT
K772126 · Lee Pharmaceuticals · Jan 1978
ORTHODONTIC BRACKET ADHESIVE
K771076 · Lee Pharmaceuticals · Jun 1977