510(k) · Cleared
ClearedBongros HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioalpha, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on May 19, 2009 as substantially equivalent to K981182 (Ceramed Dental, LLC, 1998) and 3 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- May 19, 2009
- Review
- 56 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K871773 (1987). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK871773 Bio-Oss Pure Nat Hydroxyapatite Endoss ImplantGeistlich-Pharma · 1987
- 3 generations backK033815 Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma · 2004
- 2 generations backK043034 Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc. · 2005 · Recalled
- 1 generation backK072397 Synoss Synthetic Bone Graft MaterialCollagen Matrix, Inc. · 2007
- This deviceK090793 Bongros HABioalpha, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871773 | Bio-Oss Pure Nat Hydroxyapatite Endoss Implant | Geistlich-Pharma | 1987 | — |
| −3 | K033815 | Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen | Geistlich-Pharma | 2004 | — |
| −2 | K043034 | Osteoguide Anorganic Bone Mineral Products | Collagen Matrix, Inc. | 2005 | 3 |
| −1 | K072397 | Synoss Synthetic Bone Graft Material | Collagen Matrix, Inc. | 2007 | — |
| 0 (this device) | K090793 | Bongros HA | Bioalpha, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 4 | 0 |
| 2000 | 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 LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 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 |
|---|---|---|---|
| * | K981182 | Osteograf/N-300Summary page 1…ctured and currently available in commercial distribution. Device Name Osteograf Endolion SynOss Bio-Oss 5 10(k) Number K981182 K980679 K072397 K952619 Decision SE SE SE SE… | 1998 |
| * | K980679 | EndobonSummary page 1…rrently available in commercial distribution. Device Name Osteograf Endolion SynOss Bio-Oss 5 10(k) Number K981182 K980679 K072397 K952619 Decision SE SE SE SE Product Cod… | 1998 |
| * | K072397 | Synoss Synthetic Bone Graft MaterialSummary page 1…ble in commercial distribution. Device Name Osteograf Endolion SynOss Bio-Oss 5 10(k) Number K981182 K980679 K072397 K952619 Decision SE SE SE SE Product Code LYC… | 2007 |
| * | K952619 | Bio-Oss CeramicSummary page 1…ial distribution. Device Name Osteograf Endolion SynOss Bio-Oss 5 10(k) Number K981182 K980679 K072397 K952619 Decision SE SE SE SE Product Code LYC LYC… | 1995 |
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 22 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K981182.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
Bongros®-HA (HAGS, HAGM, HAGL) is intended for use in dental surgery.
The products may be used in surgical procedures such as:
Augmentation or reconstructive treatment of the alveolar ridge
Filling of extraction sockets to enhance preservation of the alveolar ridge
Elevation of the maxillary sinus floor
Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090793: Bongros HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090793
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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