510(k) · Cleared
ClearedBioaggregate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Bioceramix, Inc. · KIF Resin, Root Canal Filling
Cleared on Nov 21, 2006 as substantially equivalent to K011009 (Dentsply International, 2001) and 3 other predicates after an 8-day review. Its family tree reaches back 3 generations to 1995. 38 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 8 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K941780 (1995). 12 ancestors in all, the oldest K852682 (1985). 38 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 2 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 1 generation backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- This deviceK063422 BioaggregateInnovative Bioceramix, Inc. · 2006
- Descendant · cites it directly · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · cites it directly · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · cites it directly · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · cites it directly37descendants
- K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · cites it directly12descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · cites it directly7descendants
- K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −2 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −1 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| 0 (this device) | K063422 | Bioaggregate | Innovative Bioceramix, Inc. | 2006 | — |
| +1 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +1 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +1 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| +2 | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 KIF? 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 KIF device
- #1 K250710 Injectable Root Canal Bioceramic Sealer (nRoot…score 14.9 · 9 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 |
|---|---|---|---|
| * | K011009 | White Mta MaterialSummary page 1…terial CLASSIFICATION NAME: Root Canal Filling Resin (21 CFR 872.3820, Product Code: KIF) PREDICATE DEVICE: Dentsply International WHITE MTA MATERIAL (K01 1009) For specific chemical compositions: • Biomet, Inc. Tantalum Beads -Radi… | 2001 |
| * | K010348 | Tantalum Beads - Radiographic MarkerSummary page 1…MTA MATERIAL (K01 1009) For specific chemical compositions: • Biomet, Inc. Tantalum Beads -Radiographic Marker (K010348) * Synthes (USA) chronOSTM(K041350) * NovaBone Products, LLC PerioGlas -… | 2001 |
| * | K041350 | Synthes (Usa) ChronosSummary page 1…fic chemical compositions: • Biomet, Inc. Tantalum Beads -Radiographic Marker (K010348) * Synthes (USA) chronOSTM(K041350) * NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particulate… | 2004 |
| * | K040278 | Perioglas-Bioglass Bone Graft SubstituteSummary page 1…* Synthes (USA) chronOSTM(K041350) * NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particulate (K040278) DEVICE DESCRIPTION: BioAggregate is a white hydraulic cement-like powder composed of biocom… | 2004 |
What descends from it? (38)
See all 384 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 2.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K080917 (Innovative Bioceramix, Inc., 2008) has gone furthest, with 37 descendants of its own.
- 5 other devices also cite its predicate K011009.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KIF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KIF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KIF
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIF
55in 2025
MAUDE reports naming product code KIF, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 31 | 0 | 2 |
| 2009 | 5 | 94 | 1 | 7 |
| 2010 | 5 | 75 | 0 | 10 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 5 | 172 | 0 | 4 |
| 2013 | 2 | — | 0 | 79 |
| 2014 | 10 | 220 | 0 | 421 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 5 | 212 | 0 | 5 |
| 2017 | 3 | 211 | 0 | 5 |
| 2018 | 5 | 147 | 0 | 13 |
| 2019 | 7 | 252 | 0 | 6 |
| 2020 | 3 | 239 | 0 | 3 |
| 2021 | 12 | 89 | 0 | 9 |
| 2022 | 3 | 152 | 0 | 10 |
| 2023 | 7 | 59 | 0 | 7 |
| 2024 | 8 | 96 | 0 | 10 |
| 2025 | 7 | 90 | 0 | 55 |
| 2026 | 7 | 108 | 0 | — |
What is it indicated for?
Repair of Root Perforation
Repair of Root Resorption
Root End Filling
Apexification
Pulp Capping
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063422: Bioaggregate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063422
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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