510(k) · Cleared

Cleared

Pontic Paint

K130237510(k) TraditionalCleared Apr 5, 201364-day reviewClass II21 CFR 872.5470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Reliance Orthodontic Products, Inc. · NXC Aligner, Sequential

Cleared on Apr 5, 2013 as substantially equivalent to K083051 (Reliance Orthodontic Products, Inc., 2009) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 2003.

Decided: Apr 5, 2013
Review: 64 days
Class: Class II
Product code: NXC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K030951 (2003). 4 ancestors in all, the oldest K880792 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK030951 Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120PBisco, Inc. · 2003
1 generation backK083051 Flowtain & Flowtain LVReliance Orthodontic Products, Inc. · 2009
This deviceK130237 Pontic PaintReliance Orthodontic Products, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K030951	Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P	Bisco, Inc.	2003	—
−1	K083051	Flowtain & Flowtain LV	Reliance Orthodontic Products, Inc.	2009	—
0 (this device)	K130237	Pontic Paint	Reliance Orthodontic Products, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
2008	1	0

FIG. 1 — Lineage of K130237, 2003–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NXC device

#1 K220287 Invisalign Systemscore 20.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K083051	Flowtain & Flowtain LV Summary page 1 …D DEVICE TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]: *Flowtain'~" with Reliance Orthodontic Products, Inc. and Plastic Conditioner: 51 0(K08305 1 and K880792, respectively). Page 18 of 54 Toll Free 1-8…	Reliance Orthodontic Products, Inc.	2009	—
*	K880792	Plastic Primer Summary page 1 …HICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]: *Flowtain'~" with Reliance Orthodontic Products, Inc. and Plastic Conditioner: 51 0(K08305 1 and K880792, respectively). Page 18 of 54 Toll Free 1-800-323-4348…	Reliance Orthodontic Products, Inc.	1988	—

Also cleared against K083051: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
None of the 4 ancestors has a recall.
4 other devices also cite its predicate K083051.

How does its category compare?

All NXC devices

NXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NXC

11in 2025

2007high 20 (2021) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NXC

61in 2025

2007high 230 (2020) · low 61 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NXC

2in 2024

2007high 2 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NXC

4,523in 2025

2007high 8,991 (2024) · low 1 (2007)2025

MAUDE reports naming product code NXC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	1
2008	2	—	0	5
2009	2	—	0	2
2010	1	—	0	11
2011	0	—	0	59
2012	2	—	0	24
2013	4	124	0	28
2014	0	—	0	27
2015	2	—	0	43
2016	1	—	0	41
2017	3	85	0	47
2018	11	116	0	67
2019	16	182	0	127
2020	16	230	0	175
2021	20	97	0	929
2022	19	137	0	605
2023	13	152	0	433
2024	14	105	2	8,991
2025	11	61	0	4,523
2026	5	127	0	—

What is it indicated for?

The Pontic Paint is intended for use as a light cure coloring agent of thermtoplastic aligners.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130237 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130237: Pontic Paint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130237

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026