510(k) · Cleared
ClearedFit Checker Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · ELW Material, Impression
Cleared on Jun 17, 2011 as substantially equivalent to K032289 (GC America, Inc., 2003) and 3 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 17, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K955932 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955932 Exaflex Impression Material (Modification)GC America, Inc. · 1996
- 1 generation backK973343 HydroflexGC America, Inc. · 1997
- This deviceK110871 Fit Checker AdvancedGC America, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK120521 GC Blue SiliconeGC America, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120521GC Blue SiliconeGC America, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955932 | Exaflex Impression Material (Modification) | GC America, Inc. | 1996 | — |
| −1 | K973343 | Hydroflex | GC America, Inc. | 1997 | — |
| 0 (this device) | K110871 | Fit Checker Advanced | GC America, Inc. | 2011 | — |
| +1 | K120521 | GC Blue Silicone | GC America, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
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 ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K032289 | Fit Checker IISummary page 1…Applcant 510(k) No. Code No Fit Checker 11 GC AMERICA, INC K(032289 ELW GO Fusion Fast (Exa'lence)* GO AMERICA, INC K043471 ELW GO Fusion… | 2003 |
| * | K043471 | Fusion FastSummary page 1…hecker 11 GC AMERICA, INC K(032289 ELW GO Fusion Fast (Exa'lence)* GO AMERICA, INC K043471 ELW GO Fusion (Exaience)* GO AMERICA, INC K041398 ELW HYDROFLE… | 2005 |
| * | K041398 | GC FusionSummary page 1…sion Fast (Exa'lence)* GO AMERICA, INC K043471 ELW GO Fusion (Exaience)* GO AMERICA, INC K041398 ELW HYDROFLEX GO AMERICA, INC K973343 ELW *Due~ to t… | 2004 |
| * | K973343 | HydroflexSummary page 1…sion (Exaience)* GO AMERICA, INC K041398 ELW HYDROFLEX GO AMERICA, INC K973343 ELW *Due~ to trademark issues, product was renamed Exa'Ience from Fusion/Sei. FDA notified August 18, 2009. 3. Dev… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120521 | GC Blue Silicone | 2012 | 0 |
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 15 years and passes through 1 company; a new generation was cleared every 13.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K120521 (GC America, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032289.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
What is it indicated for?
Checking fit of crowns, bridges, veneers, inlays and dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110871: Fit Checker Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110871
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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