510(k) · Cleared

Cleared

Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow

K122348510(k) TraditionalCleared Oct 15, 201273-day reviewClass II21 CFR 872.3760

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

Recherches Techniques Dentaires (R.T.D.) · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Oct 15, 2012 as substantially equivalent to K011788 (Stick Tech, Ltd., 2001) and 2 other predicates after a 73-day review. Its family tree reaches back 2 generations to 2001.

Decided: Oct 15, 2012
Review: 73 days
Class: Class II
Product code: EBI
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K003333 (2001). 5 ancestors in all, the oldest K955292 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003333 STICKStick Tech, Ltd. · 2001
1 generation backK011788 EverstickStick Tech, Ltd. · 2001
This deviceK122348 Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS…Recherches Techniques Dentaires (R.T.D.) · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003333	STICK	Stick Tech, Ltd.	2001	—
−1	K011788	Everstick	Stick Tech, Ltd.	2001	—
0 (this device)	K122348	Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow	Recherches Techniques Dentaires (R.T.D.)	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	1	0
2003	1	0

FIG. 1 — Lineage of K122348, 2001–2012Source: 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 EBI? 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 EBI device

#1 K250617 Apex Flexscore 18.3 · 1 generation · 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? (4)

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
*	K011788	Everstick Summary page 1 …duct Code EBI) e Material, tooth'shade, resin (21 CFR 872.3690, Product Code EBF) 7. Predicate Device(s): Device: EVERSTICK. Manufacturer; STICK TECH LTD 510(k) Number: K011788 - Device: SPLINT-IT Manufacturer: PENTRON INC 510(k) Number: K972985 Device: RIBBOND _ Manufacturer: RIBBOND Inc Section 5- Pa…	Stick Tech, Ltd.	2001	—
*	K972985	Splint IT Summary page 1 …t Code EBF) 7. Predicate Device(s): Device: EVERSTICK. Manufacturer; STICK TECH LTD 510(k) Number: K011788 - Device: SPLINT-IT Manufacturer: PENTRON INC 510(k) Number: K972985 Device: RIBBOND _ Manufacturer: RIBBOND Inc Section 5- Page 1 of 3 RTD . 3, rue Louis Neel Technoparé Espace Gavaniére - 38120…	Jeneric/Pentron, Inc.	1997	—
*	K031341	Stick Flow Summary page 3 …-4 DENTAIRES 510(k) Number K913040 Device: EVERSTICK Manufacturer: STICK TECH LTD 510(k) Number: K031341 8. Description of the Device: Quartz Splint is made of quartz fibers impregnated a light-cured resin matrix. Quartz Splint i…	Stick Tech, Ltd.	2003	—
*	—	Ribbond Named without a submission number			—

Also cleared against K011788: 7 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 11 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
None of the 5 ancestors has a recall.
7 other devices also cite its predicate K011788.

How does its category compare?

All EBI devices

EBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · EBI

11in 2025

2007high 11 (2011) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBI

79in 2025

2007high 283 (2020) · low 53 (2007)2026

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

Recalls per year · EBI

2in 2022

2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · EBI

34in 2025

2007high 34 (2025) · low 1 (2024)2025

MAUDE reports naming product code EBI, 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	10	53	0	7
2008	6	124	0	2
2009	3	234	0	5
2010	4	95	0	4
2011	11	113	0	6
2012	3	85	0	9
2013	5	135	0	5
2014	5	102	0	9
2015	9	106	0	8
2016	7	147	0	9
2017	8	196	0	2
2018	5	158	2	2
2019	4	127	0	10
2020	6	283	0	8
2021	4	99	0	25
2022	11	154	2	2
2023	11	96	0	13
2024	9	90	0	1
2025	11	79	0	34
2026	7	87	0	—

What is it indicated for?

The splinting system is designed for use in oral splintings otto support laboratory-processes composite bridge/denture work * QUARTZ SPLINT"" UD (Unidirectional): Composite laboratory bridge strengthening/ reinforcement * QUARTZ SPLINTTM WOVEN: Direct Splinting/Bridge and Implant positioning reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy. * QUARTZ SPLINrM ROPE…

Read the full statement (119 words)

The splinting system is designed for use in oral splintings otto support laboratory-processes composite bridge/denture work

* QUARTZ SPLINT"" UD (Unidirectional): Composite laboratory bridge strengthening/

reinforcement

* QUARTZ SPLINTTM WOVEN: Direct Splinting/Bridge and Implant positioning

reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of

teeth subsequent to orthodontic therapy.

* QUARTZ SPLINrM ROPE: Laboratory splint fabrication for bridge reinforcemnent or

denture repair. Periodontal splinting of mobile teeth iitClinical use.

* QUARTZ SPLINTTM MESH: Denture reinforcement and denture repair:

* QUARTZ SPLINT"' RESIN: for additional wetting during the application of the finished

splints

* QS.FLOWTm: a nano filIed, light cured flowable composite designed to be used with the

QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K122348 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122348: Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122348

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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