Cleared Traditional

K875145 - MAR BOND

K875145 is an FDA 510(k) clearance for MAR BOND, manufactured by Reliance Orthodontic Products, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K875145 · Reliance Orthodontic Products, Inc. · Dental device
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Feb 1988
Decision
73d
Days
Class 2
Risk

K875145 is an FDA 510(k) clearance for the MAR BOND. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on February 26, 1988 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Reliance Orthodontic Products, Inc. devices

FDA 510(k) Submission Details - K875145

510(k) Number K875145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date February 26, 1988
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 151
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K875145.
PROTEMP II
K900436 · Espe GmbH (Us) · Mar 1990
UNIFAST LC
K890829 · G-C Intl. Corp. · Apr 1989
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988
INTEGRITY
K853052 · Dentsply Intl. · Aug 1985
INTERIM TEMP. CROWN & BRIDGE RESIN
K833261 · Coe Laboratories, Inc. · Jan 1984
DENTALON
K831077 · Kulzer, Inc. · Sep 1983