Cleared Traditional

K880791 - MAXIMUM CURE SEALANT

K880791 is the FDA 510(k) clearance for MAXIMUM CURE SEALANT by Reliance Orthodontic Products, Inc.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K880791 · Reliance Orthodontic Products, Inc. · Dental device
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Jun 1988
Decision
108d
Days
Class 2
Risk

K880791 is an FDA 510(k) clearance for the MAXIMUM CURE SEALANT. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on June 13, 1988 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 Reliance Orthodontic Products, Inc. devices

Submission Details

510(k) Number K880791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date June 13, 1988
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 K880791.
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834 · Scientific Pharmaceuticals, Inc. · May 1989
FRS LITE FLUORIDE RELEASING SEALANT
K890740 · Ormco Corp. · Apr 1989
ORTHO-SEAL
K883465 · Bisco, Inc. · Oct 1988
LIGHT BOND
K880793 · Reliance Orthodontic Products, Inc. · Jun 1988
RELIANCE METAL PRIMER
K880766 · Reliance Orthodontic Products, Inc. · Apr 1988
PORCELAIN PRIMER
K880790 · Reliance Orthodontic Products, Inc. · Apr 1988