510(k) · Cleared
ClearedCSM Internal-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 Apr 27, 2012 as substantially equivalent to K090527 (Neobiotech Co., Ltd., 2009) and 1 other predicate after a 113-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Apr 27, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K944964 (1995). 61 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 2 generations backK050635 Allfim Implant SystemsCowellmedi Co., Ltd. · 2005
- 1 generation backK071148 Atlas Implant SystemCowellmedi Co., Ltd. · 2008
- This deviceK120043 CSM Internal-R Implant SystemCsm Implant · 2012
- Descendant · cites it directly · 0 of its ownK173141 CSM Submerged3-L Implant SystemCsm Implant · 2018
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 |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −2 | K050635 | Allfim Implant Systems | Cowellmedi Co., Ltd. | 2005 | — |
| −1 | K071148 | Atlas Implant System | Cowellmedi Co., Ltd. | 2008 | — |
| 0 (this device) | K120043 | CSM Internal-R Implant System | Csm Implant | 2012 | — |
| +1 | K173141 | CSM Submerged3-L Implant System | Csm Implant | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K090527 | Sinus Quick IT SystemSummary page 2…dicate Devices & Comparison The subject device is substantially equivalent to the following predicate device: * SQ IT System manufactured by Neobiotech Co., Ltd. (K090527) * Atlas Implant System manufactured by CowellMedi Co., Ltd. (K071 148) Testing and other comparisons have established that t… | 2009 |
| * | K071148 | Atlas Implant SystemSummary page 2…nt to the following predicate device: * SQ IT System manufactured by Neobiotech Co., Ltd. (K090527) * Atlas Implant System manufactured by CowellMedi Co., Ltd. (K071 148) Testing and other comparisons have established that the subject of CSM Internal-R Implant System is substantially equivalent in… | 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 17 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 61 ancestors have a recall of any class.
- Of its descendants, K173141 (Csm Implant, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090527.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Internal-R Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or over denture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120043 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120043: CSM Internal-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/K120043
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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