510(k) · Cleared
ClearedCSM Submerged-R Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Csm Implant · DZE Implant, Endosseous, Root-Form
Cleared on Oct 14, 2011 as substantially equivalent to K090825 (Neobiotech Co., Ltd., 2009) and 1 other predicate after a 176-day review. Its family tree reaches back 11 generations to 1996. 8 later devices descend from it.
- Decided
- Oct 14, 2011
- Review
- 176 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K960026 (1996). 46 ancestors in all, the oldest K894595 (1990). 8 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 1 generation backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- This deviceK111120 CSM Submerged-R Implant SystemCsm Implant · 2011
- Descendant · cites it directly · 7 of its ownK153350 IBS Implant SystemInnobiosurg Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK162099 IBS Implant System IIInnobiosurg Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK173120 CCM Abutment SystemInnobiosurg Co., Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK202418 Magic UCLA Abutment SystemInnobiosurg Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK212517 Magicore SystemInnobiosurg Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 1 generation backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- This deviceK111120 CSM Submerged-R Implant SystemCsm Implant · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153350IBS Implant SystemInnobiosurg Co., Ltd. · 2016 · cites it directly7descendants
- K162099IBS Implant System IIInnobiosurg Co., Ltd. · 2017 · 2 generations on5descendants
- K173120CCM Abutment SystemInnobiosurg Co., Ltd. · 2018 · 2 generations on3descendants
- K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd. · 2020 · 3 generations on2descendants
- K212517Magicore SystemInnobiosurg Co., Ltd. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −1 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| 0 (this device) | K111120 | CSM Submerged-R Implant System | Csm Implant | 2011 | — |
| +1 | K153350 | IBS Implant System | Innobiosurg Co., Ltd. | 2016 | — |
| +2 | K162099 | IBS Implant System II | Innobiosurg Co., Ltd. | 2017 | — |
| +2 | K173120 | CCM Abutment System | Innobiosurg Co., Ltd. | 2018 | — |
| +3 | K202418 | Magic UCLA Abutment System | Innobiosurg Co., Ltd. | 2020 | — |
| +3 | K212517 | Magicore System | Innobiosurg Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K090825 | SQ IS SystemSummary page 2…dicate Devices & Comparison The subject device is substantially equivalent to the following predicate device: 0SQ IS System manufactured by Neobiotech Co., Ltd. (K090825) Testing and other comparisons have established that the subject of CSM submerged-R Implant System is substantially equivalent i… | 2009 |
| * | K093321 | Biohorizons Laser-Lok 3.0 Implant SystemSummary page 3…nt Substantial equivalence chart summary The CSM submerged-R Implant System has a substantially equivalent intended use as the identified predicate, SQ IS System (K093321) manufactured by Neobiotech Co., Ltd. and is made of titanium metal intended to be surgically placed in the bone of the upper or… | 2010 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153350 | IBS Implant System | 2016 | 7 |
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 9 months on median.
- 6 of the 46 ancestors have a recall of any class.
- Of its descendants, K153350 (Innobiosurg Co., Ltd., 2016) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K090825.
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?
The CSM submerged-R Implant System is especially designed for use in dental implant surgery. According to the widely accepted clinical studies successful osseointegration between fixture and the live bone depends on surgical implantation under proper conditions, shape of fixture and surface treatment technique. Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. In case…
Read the full statement (133 words)
The CSM submerged-R Implant System is especially designed for use in dental implant surgery. According to the widely accepted clinical studies successful osseointegration between fixture and the live bone depends on surgical implantation under proper conditions, shape of fixture and surface treatment technique. Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. In case of Customized Hand Milling Abutment, its wall thickness is 2mm and height is 12mm. It can be reduced into Max. 7mm. The margin of the product can be modified up to Max 200. In case of Non-Hex Cementation Abutment, it is a bridge type. Two or more products must be used. Under part of abutment is made in round shape in order to avoid restriction in connecting work.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111120: CSM Submerged-R Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111120
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