510(k) · Cleared
ClearedOssatura Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis Orthobiologics, Inc. · LYC Bone Grafting Material, Synthetic
Cleared on Oct 20, 2004 as substantially equivalent to K860983 (Interpore Intl., 1986) and 1 other predicate after a 20-day review. Its family tree reaches back 1 generation to 1986. 6 later devices descend from it.
- Decided
- Oct 20, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K860983 (1986). 2 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK860983 Interpore 200 Porous HydroxyapatiteInterpore Intl. · 1986
- This deviceK042706 Ossatura DentalIsotis Orthobiologics, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · 3 generations on · 0 of its ownK213260 CMFlexTMDimension Inx Corp. · 2022
- Descendant · cites it directly · 0 of its ownK201546 OsOpia Synthetic Bone Void FillerRevisios BV · 2020
- Descendant · cites it directly · 0 of its ownK093122 MBCP+Biomatlante · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009 · cites it directly2descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 2 generations on1descendant
- K213260CMFlexTMDimension Inx Corp. · 2022 · 3 generations on0descendants
- K201546OsOpia Synthetic Bone Void FillerRevisios BV · 2020 · cites it directly0descendants
- K093122MBCP+Biomatlante · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860983 | Interpore 200 Porous Hydroxyapatite | Interpore Intl. | 1986 | — |
| 0 (this device) | K042706 | Ossatura Dental | Isotis Orthobiologics, Inc. | 2004 | — |
| +1 | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009 | — |
| +2 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +3 | K213260 | CMFlexTM | Dimension Inx Corp. | 2022 | — |
| +1 | K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | 2020 | — |
| +1 | K093122 | MBCP+ | Biomatlante | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K860983 | Interpore 200 Porous HydroxyapatiteSummary page 1…c bone graft material Classification Name: Bone filling augmentation (Unclassified) 3. PREDICATE DEVICES Interpore 200 porous hydroxyapatite ® (K 860983) BioOss Collagen (K974399) 4. DEVICE DESCRIPTION OsSaturaTM Dental is a synthetic, osteoconductive bone voi… | 1986 |
| * | K974399 | Bio-Oss CollagenSummary page 1…fication Name: Bone filling augmentation (Unclassified) 3. PREDICATE DEVICES Interpore 200 porous hydroxyapatite ® (K 860983) BioOss Collagen (K974399) 4. DEVICE DESCRIPTION OsSaturaTM Dental is a synthetic, osteoconductive bone void filler, which consists of… | 1998 |
What descends from it? (6)
4 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?
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
OsSaturaT m Dental is a bone filling material indicated for augmentation or reconstructive
treatment of the alveolar ridge. This includes:
- Filling of defects after root resection, apicoectomy and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Treatment of periodontal defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042706 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042706: Ossatura Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042706
Report an extraction error
Are you the manufacturer?
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