Cleared Traditional

K991481 - PARAGON

K991481 is the FDA 510(k) clearance for PARAGON by Lancer Orthodontics, Inc.. It is a Class 2 Dental device (product code EJJ) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K991481 · Lancer Orthodontics, Inc. · Dental device
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Aug 1999
Decision
105d
Days
Class 2
Risk

K991481 is an FDA 510(k) clearance for the PARAGON. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Lancer Orthodontics, Inc. (San Marcos, US). The FDA issued a Cleared decision on August 11, 1999 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Lancer Orthodontics, Inc. devices

Submission Details

510(k) Number K991481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date August 11, 1999
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 14
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K991481.
CENTURY ALLOY
K974035 · Dentsply Intl. · Dec 1997
SYBRALOY
K940675 · Sybron Dental Specialties, Inc. · Apr 1994
DW 236
K905204 · Ivoclar North America, Inc. · Mar 1991
DW 235
K905205 · Ivoclar North America, Inc. · Dec 1990
VIVAALLOY HR (AMALGAM)
K901911 · Ivoclar North America, Inc. · Jun 1990
AMALCAP PLUS
K901256 · Ivoclar North America, Inc. · Apr 1990