510(k) · Cleared
ClearedBioHPP - breCAM.BioHPP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bredent GmbH & Co. KG · EBF Material, Tooth Shade, Resin
Cleared on Jul 21, 2016 as substantially equivalent to K133608 (Bicon, LLC, 2014) and 1 other predicate after a 358-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it.
- Decided
- Jul 21, 2016
- Review
- 358 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K043504 (2005). 8 ancestors in all, the oldest K992956 (1999). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK043504 PalaimpactHeraeus Kulzer, Inc. · 2005
- 2 generations backK111832 Paladon Ultra Powder (Pink), Paladon Ultra LiquidHeraeus Kulzer, LLC · 2011
- 1 generation backK132725 Juvora Dentqal DiscJuvora · 2014
- This deviceK152113 BioHPP - breCAM.BioHPPBredent GmbH & Co. KG · 2016
- Descendant · cites it directly · 0 of its ownK181484 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med…Zirkonzahn Srl · 2018
- Descendant · cites it directly · 0 of its ownK173124 PEEK BiosolutionMerz Dental GmbH · 2017
- Descendant · cites it directly · 0 of its ownK170102 Pekkton IvoryCendres+Metaux SA · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K043504 | Palaimpact | Heraeus Kulzer, Inc. | 2005 | — |
| −2 | K111832 | Paladon Ultra Powder (Pink), Paladon Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| −1 | K132725 | Juvora Dentqal Disc | Juvora | 2014 | — |
| 0 (this device) | K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016 | — |
| +1 | K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral… | Zirkonzahn Srl | 2018 | — |
| +1 | K173124 | PEEK Biosolution | Merz Dental GmbH | 2017 | — |
| +1 | K170102 | Pekkton Ivory | Cendres+Metaux SA | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K133608 | TriniaSummary page 6…s, already cleared by the FDA: Predicate Device 510(k) Number 510(k) Holder TRINIA K133608 BICON, LLC 501 Arborway… | 2014 |
| * | K132725 | Juvora Dentqal DiscSummary page 6…501 Arborway Boston, MA 02130 Juvora PEEK K132725 JUVORA Technology Centre Hillhous… | 2014 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K181484 (Zirkonzahn Srl, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
BioHPP polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering. • Fully anatomical crowns and bridges (max. 2 pontics) • Crown copings and bridge substructures for composite veneers (max. 2 pontics) • Telescopic primary and secondary crowns and…
Read the full statement (172 words)
BioHPP polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering.
• Fully anatomical crowns and bridges (max. 2 pontics)
• Crown copings and bridge substructures for composite veneers (max. 2 pontics)
• Telescopic primary and secondary crowns and frameworks
• Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide
breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques.
Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector cross-section)
Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm² connector cross-section))
Telescopic primary and secondary crowns and frameworks Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. Reference is made to the instructions for use “BioHPP elegance prefab for SKY” to fabricate an individual abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152113: BioHPP - breCAM.BioHPP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152113
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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