510(k) · Cleared
ClearedApolonia Laser Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Csm Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 22, 2011 as substantially equivalent to K073268 (BioHorizons Implant Systems, Inc., 2008) after a 190-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Mar 22, 2011
- Review
- 190 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K960026 (1996). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 5 generations between
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
- 1 generation backK073268 Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · Recalled
- This deviceK102635 Apolonia Laser Implant SystemCsm Implant Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK173141 CSM Submerged3-L Implant SystemCsm Implant · 2018
Show all 9 generations
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 7 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 6 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
- 1 generation backK073268 Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · Recalled
- This deviceK102635 Apolonia Laser Implant SystemCsm Implant Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K173141CSM Submerged3-L Implant SystemCsm Implant · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −8 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −2 | K042429 | The Prodigy System Dental Implants | BioHorizons Implant Systems, Inc. | 2004 | — |
| −1 | K073268 | Biohorizons Internal Implant System | BioHorizons Implant Systems, Inc. | 2008 | 1 |
| 0 (this device) | K102635 | Apolonia Laser Implant System | Csm Implant Co., Ltd. | 2011 | — |
| +1 | K173141 | CSM Submerged3-L Implant System | Csm Implant | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K073268 | Biohorizons Internal Implant SystemSummary page 1…d loading. Predicate Devices & Comparison The subject device is substantially equivalent to the following predicate device: Biohorizos Internal Implant system(K073268) 7 CSM submerged-L Implant System… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173141 | CSM Submerged3-L Implant System | 2018 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K173141 (Csm Implant, 2018) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K073268.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102635: Apolonia Laser Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102635
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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