Cleared Traditional

K130237 - PONTIC PAINT

K130237 is an FDA 510(k) clearance for PONTIC PAINT, manufactured by Reliance Orthodontic Products, Inc.. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K130237 · Reliance Orthodontic Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
64d
Days
Class 2
Risk

K130237 is an FDA 510(k) clearance for the PONTIC PAINT. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on April 5, 2013 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 - K130237

510(k) Number K130237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2013
Decision Date April 05, 2013
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NXC Device Classification - Class 2, Special Controls

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
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 - NXC Aligner, Sequential

All 137
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K130237.
CLEARPATH ALIGNER
K123514 · Qserve America, Inc. · Nov 2013
MTM(R) CLEAR ALIGNER
K132145 · Dentsply International, Inc. · Oct 2013
MTM CLEAR ALIGNER IN-OFFICE
K123925 · Dentsply International, Inc. · May 2013
DYNAFLEX
K121396 · Dyna Flex · Aug 2012
CLEARCORRECT SYSTEM
K113618 · Clearcorrect, Inc. · Mar 2012
ALIGN SYSTEM
K981095 · Align Technology · Sep 1998