510(k) · Cleared
ClearedHTFX-222
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Apr 9, 2014 as substantially equivalent to K123631 (GC America, Inc., 2013) and 4 other predicates after a 174-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Apr 9, 2014
- Review
- 174 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K042819 (2004). 6 ancestors in all, the oldest K032921 (2003). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −2 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −1 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| 0 (this device) | K133182 | HTFX-222 | GC America, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K123631 | MFP-051Summary page 1…Company Device 510(k) No. Date Cleared GC America Inc. MFP-051 K123631 07/23/2013 GC America Inc. GC KALORE (GDLS-200) K082434 11/14/2008 GC AMER… | 2013 |
| * | K082434 | GDLS-200Summary page 1…GC America Inc. MFP-051 K123631 07/23/2013 GC America Inc. GC KALORE (GDLS-200) K082434 11/14/2008 GC AMERICA, INC 0-aenial Universal Flo (GCUC-505) K09 1388 07/22/2009 KERR CO… | 2008 |
| * | K091388 | GCUC-505Summary page 1…GC America Inc. GC KALORE (GDLS-200) K082434 11/14/2008 GC AMERICA, INC 0-aenial Universal Flo (GCUC-505) K09 1388 07/22/2009 KERR CORPORATION PREMISE K032921 11/13/2003 Ivoelar… | 2009 |
| * | K032921 | PremiseSummary page 1…GC AMERICA, INC 0-aenial Universal Flo (GCUC-505) K09 1388 07/22/2009 KERR CORPORATION PREMISE K032921 11/13/2003 Ivoelar Vivadent. Inc. Tetric Evoceram K042819 11/09/2004 4. Descrip… | 2003 |
| * | K042819 | Tetric EvoceramSummary page 1…KERR CORPORATION PREMISE K032921 11/13/2003 Ivoelar Vivadent. Inc. Tetric Evoceram K042819 11/09/2004 4. Description of Device: HTFX-222 is a light cured nano-filled radiopaque composite resin filled in a s… | 2004 |
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 4.0 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K123631.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
1. Liner or base
2. Blocking out undercuts
3. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
4. Sealing hypersensitive areas
5. Fissure sealant
6. Direct restorative for small Class 1,11, 111, IV, and V cavities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133182: HTFX-222.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133182
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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