510(k) Report

510(k) · Cleared

Cleared

STICK

K003333510(k) TraditionalCleared Jan 4, 200171-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

Stick Tech, Ltd. · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Jan 4, 2001 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Jan 4, 2001
Review
71 days
Class
Class II
Product code
EBI
Recalls
None
Predicates
0

11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2007: 1 descendant cleared2003: 3 descendants cleared2012: 1 descendant cleared2010: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2006: 2 descendants cleared200020052010201520202025
  1. This deviceK003333 STICKStick Tech, Ltd. · 2001
  2. Descendant · cites it directly · 10 of its ownK011788 EverstickStick Tech, Ltd. · 2001
  3. Descendant · 2 generations on · 2 of its ownK030072 Everstick PerioStick Tech, Ltd. · 2003
  4. Descendant · 2 generations on · 1 of its ownK030820 Everstick PostStick Tech, Ltd. · 2003
  5. Descendant · 2 generations on · 1 of its ownK021126 Everstick OrthoStick Tech, Ltd. · 2002
  6. Descendant · 2 generations on · 0 of its ownK122348 Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS…Recherches Techniques Dentaires (R.T.D.) · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 32004: 12006: 22007: 12010: 12012: 1
2001high 3 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all
  • K011788EverstickStick Tech, Ltd. · 2001 · cites it directly10descendants
  • K030072Everstick PerioStick Tech, Ltd. · 2003 · 2 generations on2descendants
  • K030820Everstick PostStick Tech, Ltd. · 2003 · 2 generations on1descendant
  • K021126Everstick OrthoStick Tech, Ltd. · 2002 · 2 generations on1descendant
  • K122348Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS FlowRecherches Techniques Dentaires (R.T.D.) · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003333STICKStick Tech, Ltd.2001—
+1K011788EverstickStick Tech, Ltd.2001—
+2K030072Everstick PerioStick Tech, Ltd.2003—
+2K030820Everstick PostStick Tech, Ltd.2003—
+2K021126Everstick OrthoStick Tech, Ltd.2002—
+2K122348Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS FlowRecherches Techniques Dentaires (R.T.D.)2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200330
200410
200620
200710
201010
201210
FIG. 1 — Lineage of K003333, 2001–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011788EverstickStick Tech, Ltd.200110
K063170Tender FiberMicerium S.P.A.20070
K031070Carbon Fiber Bridge, Model 28757Nobel Biocare AB20030

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?

  • Of its descendants, K011788 (Stick Tech, Ltd., 2001) has gone furthest, with 10 descendants of its own.

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.

FDA decisions per year · EBI

11in 2025

2007: 102008: 62009: 32010: 42011: 112012: 32013: 52014: 52015: 92016: 72017: 82018: 52019: 42020: 62021: 42022: 112023: 112024: 92025: 112026 (partial year): 7
2007high 11 (2011) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBI

79in 2025

2007: 53 days median2008: 124 days median2009: 234 days median2010: 95 days median2011: 113 days median2012: 85 days median2013: 135 days median2014: 102 days median2015: 106 days median2016: 147 days median2017: 196 days median2018: 158 days median2019: 127 days median2020: 283 days median2021: 99 days median2022: 154 days median2023: 96 days median2024: 90 days median2025: 79 days median2026 (partial year): 87 days median
2007high 283 (2020) · low 53 (2007)2026

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

Recalls per year · EBI

2in 2022

2018: 22022: 2
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

2007: 72008: 22009: 52010: 42011: 62012: 92013: 52014: 92015: 82016: 92017: 22018: 22019: 102020: 82021: 252022: 22023: 132024: 12025: 34
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007105307
2008612402
2009323405
201049504
20111111306
201238509
2013513505
2014510209
2015910608
2016714709
2017819602
2018515822
20194127010
2020628308
2021499025
20221115422
20231196013
202499001
20251179034
20267870—
Cite this page

510(k) Report. “K003333: STICK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003333

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026