510(k) · Cleared
ClearedSocket Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steiner Laboratories · LYC Bone Grafting Material, Synthetic
Cleared on Jan 27, 2012 as substantially equivalent to K052493 (Steiner Laboratories, 2006) and 4 other predicates after a 106-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jan 27, 2012
- Review
- 106 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K960978 (1996). 38 ancestors in all, the oldest K955096 (1996). No later device cites it as a predicate yet.
- Root · 8 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 7 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 6 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 5 generations backK052494 Novabone-Bioactive Synthetic GraftNovabone Products, LLC · 2005
- 4 generations backK072184 Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc. · 2007
- 3 generations backK081439 Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc. · 2008
- 2 generations backK083033 Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister…Orthovita, Inc. · 2008
- 1 generation backK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- This deviceK113049 Socket GraftSteiner Laboratories · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −7 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −6 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −5 | K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | 2005 | — |
| −4 | K072184 | Vitoss Bioactive Foam Bone Graft Substitute | Orthovita, Inc. | 2007 | — |
| −3 | K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | Orthovita, Inc. | 2008 | — |
| −2 | K083033 | Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam &… | Orthovita, Inc. | 2008 | — |
| −1 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| 0 (this device) | K113049 | Socket Graft | Steiner Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K052493 | Socket GraftSummary page 1…ynthetic, Oral Product Classification: NPK Proprietary Name: SOCKET SEAL SOCKET GRAFT grafting material is substantially equivalent to: 1) Socket Graft K052493 2) EquivaBone Osteoindluctive Bone Graft K090855 3) CalMatrix Calcium Sulfate Bone Graft K041324 SOCKET SEAL is substantially eq… | 2006 |
| * | K090855 | Equivabone Osteoinductive Bone Graft SubstituteSummary page 1…roprietary Name: SOCKET SEAL SOCKET GRAFT grafting material is substantially equivalent to: 1) Socket Graft K052493 2) EquivaBone Osteoindluctive Bone Graft K090855 3) CalMatrix Calcium Sulfate Bone Graft K041324 SOCKET SEAL is substantially equivalent to: 1) IMTEC BioBarrier Membrane K97475… | 2009 |
| * | K041324 | Calmatrix Calcium Sulfate Bone Graft BinderSummary page 1…GRAFT grafting material is substantially equivalent to: 1) Socket Graft K052493 2) EquivaBone Osteoindluctive Bone Graft K090855 3) CalMatrix Calcium Sulfate Bone Graft K041324 SOCKET SEAL is substantially equivalent to: 1) IMTEC BioBarrier Membrane K974752 2)Tefgen-LS K965205… | 2004 |
| * | K974752 | Imtec/Biobarrier MembraneSummary page 1…EquivaBone Osteoindluctive Bone Graft K090855 3) CalMatrix Calcium Sulfate Bone Graft K041324 SOCKET SEAL is substantially equivalent to: 1) IMTEC BioBarrier Membrane K974752 2)Tefgen-LS K965205 k o3oyq DE… | 1998 |
| * | K965205 | Tefgen - LSSummary page 1…luctive Bone Graft K090855 3) CalMatrix Calcium Sulfate Bone Graft K041324 SOCKET SEAL is substantially equivalent to: 1) IMTEC BioBarrier Membrane K974752 2)Tefgen-LS K965205 k o3oyq DEVICE DESCRIPTION SO… | 1997 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 38 ancestors have a recall of any class.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining.
Socket Seal is' a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113049: Socket Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113049
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