510(k) · Cleared
ClearedOdoncer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teknimed, S.A. · LYC Bone Grafting Material, Synthetic
Cleared on Apr 16, 2007 as substantially equivalent to K053374 (Ossacur AG, 2006) and 2 other predicates after a 266-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Apr 16, 2007
- Review
- 266 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941780 (1995). 20 ancestors in all, the oldest P800035 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 4 generations backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- 3 generations backK040278 Perioglas-Bioglass Bone Graft SubstituteNovabone Products, LLC · 2004
- 2 generations backK051443 Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility · 2005
- 1 generation backK053374 Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG · 2006
- This deviceK062102 OdoncerTeknimed, S.A. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −4 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| −3 | K040278 | Perioglas-Bioglass Bone Graft Substitute | Novabone Products, LLC | 2004 | — |
| −2 | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio | Curasan Ag, Frankfurt Facility | 2005 | — |
| −1 | K053374 | Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM) | Ossacur AG | 2006 | — |
| 0 (this device) | K062102 | Odoncer | Teknimed, S.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K053374 | Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Summary page 1…grafting material for dental bone repair Class IIper 21 CFR section 888.3045 Product Code LPK Equivalent Device OSSAPLAST Dental (K053374) (OssascurAG) CALC-I-OSS (K042583) (Ultradent Products) Cerasob M Dental (K051443} (Cur… | 2006 |
| * | K042583 | Calc-I-OssSummary page 1…Class IIper 21 CFR section 888.3045 Product Code LPK Equivalent Device OSSAPLAST Dental (K053374) (OssascurAG) CALC-I-OSS (K042583) (Ultradent Products) Cerasob M Dental (K051443} (Curasan AG) Device Description ODONCER is an osseo-conduct… | 2005 |
| * | K051443 | Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioSummary page 1…LPK Equivalent Device OSSAPLAST Dental (K053374) (OssascurAG) CALC-I-OSS (K042583) (Ultradent Products) Cerasob M Dental (K051443} (Curasan AG) Device Description ODONCER is an osseo-conductive powder implant made of synthetic beta tricalcium phosphate (l3-TC… | 2005 |
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 12 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 20 ancestors has a recall.
- 1 other device also cites its predicate K053374.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
ODONCER Bone Grafting Material is recommended for:
Augmentation or reconstructive treatment of the alveolar ridge.
Filling of infrabony periodontal defects.
Filling of defects after root resection, apicoectomy, and cystectomy.
Filling of extraction sockets to enhance preservation of the alveolar ridge.
Elevation of the maxillary sinus floor.
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration and Guided Bone Regeneration.
Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062102: Odoncer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062102
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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