510(k) · Cleared

Cleared

Clear Aligner Adhesive

K123348510(k) TraditionalCleared Feb 28, 2013120-day reviewClass II21 CFR 872.3750

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. · DYH Adhesive, Bracket And Tooth Conditioner, Resin

Cleared on Feb 28, 2013 as substantially equivalent to K083051 (Reliance Orthodontic Products, Inc., 2009) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 2003.

Decided: Feb 28, 2013
Review: 120 days
Class: Class II
Product code: DYH
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 deviceK123348 Clear Aligner AdhesiveReliance 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)	K123348	Clear Aligner Adhesive	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 K123348, 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 DYH? 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 DYH device

#1 K261840 BracePaste Prime Plusscore 13.8 · 9 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 …ED DEVICE TO WICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) 1807.92(a) (3),1: * FlowtainTMAwith Reliance Orthodontic Products, Inc. and Plastic Conditioner: 5 l0(K083051I and K880792, respectively). Page l8of5f) ~e~kar…	Reliance Orthodontic Products, Inc.	2009	—
*	K880792	Plastic Primer Summary page 1 …WICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) 1807.92(a) (3),1: * FlowtainTMAwith Reliance Orthodontic Products, Inc. and Plastic Conditioner: 5 l0(K083051I and K880792, respectively). Page l8of5f) ~e~kar…	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 DYH devices

DYH Adhesive, Bracket And Tooth Conditioner, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DYH

1in 2025

2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYH

143in 2020

2007high 143 (2020) · low 62 (2007)2026

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

Recalls per year · DYH

1in 2007

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DYH

1in 2025

2007high 5 (2010) · low 0 (2013)2025

MAUDE reports naming product code DYH, 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	3	62	1	2
2008	6	72	0	1
2009	3	77	0	1
2010	4	96	0	5
2011	2	—	0	1
2012	3	82	0	3
2013	1	—	0	0
2014	0	—	0	2
2015	5	135	0	2
2016	2	—	0	1
2017	0	—	0	5
2018	1	—	0	0
2019	1	—	0	0
2020	3	143	0	0
2021	1	—	0	0
2022	1	—	0	0
2023	2	—	0	0
2024	1	—	0	0
2025	1	—	0	1
2026	3	87	0	—

What is it indicated for?

The CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123348 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123348: Clear Aligner Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123348

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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