510(k) Report

510(k) · Cleared

Cleared

Eversticknet

K011799510(k) TraditionalCleared Nov 5, 2001150-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 Nov 5, 2001 as substantially equivalent to K003334 (Stick Tech, Ltd., 2001) after a 150-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided
Nov 5, 2001
Review
150 days
Class
Class II
Product code
EBI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003334 (2001). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant clearedK003334 · Stick Net · Stick Tech, Ltd. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K003334 · Stick Net · Stick Tech, Ltd. · 20010
  1. Root · 1 generation backK003334 Stick NetStick Tech, Ltd. · 2001
  2. This deviceK011799 EversticknetStick Tech, Ltd. · 2001
  3. Descendant · cites it directly · 0 of its ownK102207 Fiber ForceSynca Marketing, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K102207Fiber ForceSynca Marketing, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003334Stick NetStick Tech, Ltd.2001—
0 (this device)K011799EversticknetStick Tech, Ltd.2001—
+1K102207Fiber ForceSynca Marketing, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K011799, 2001–2010Source: 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), 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. #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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K003334Stick Net
Summary page 2
…uired post-trauma, post-operative, or for orthodontic therapy. F-2 everStickNet™ is substantially equivalent to fibreNet™, approved under 510(k) number K003334 dated January 8, 2001. Testing which has been performed on everStickNet™ indicates that the device has the same intended use bu…
Stick Tech, Ltd.2001—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102207Fiber ForceSynca Marketing, Inc.20100

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?

  • Its one ancestor has no recall.
  • Of its descendants, K102207 (Synca Marketing, Inc., 2010) has gone furthest, with 0 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—

What is it indicated for?

As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances.

As reinforcement for temporary and/or permanent plastic/composite partial and full crowns and bridges.

As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or orthodontic therapy.

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

Cite this page

510(k) Report. “K011799: Eversticknet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011799

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026