Cleared Traditional

K991481 - PARAGON

K991481 is an FDA 510(k) clearance for PARAGON, manufactured by Lancer Orthodontics, Inc.. The device is a Class 2 Dental device with 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.

FDA 510(k) Submission Details - K991481

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 128d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJJ Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K991481.
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
K002808 · Nordiska Dental AB · Oct 2000
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
K002810 · Nordiska Dental AB · Oct 2000
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
K002811 · Nordiska Dental AB · Oct 2000
SECURALLOY
K982671 · Specialites Septodont · Oct 1998
AMALCAP PLUS
K982456 · Ab Ardent · Aug 1998
VIVALLOY HR
K982458 · Ab Ardent · Aug 1998
K991481 · PARAGON
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