510(k) · Cleared
ClearedINNO SLA Submerged Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cowellmedi Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 25, 2022 as substantially equivalent to K132242 (Cowellmedi Co., Ltd., 2013) and 1 other predicate after a 617-day review. Its family tree reaches back 11 generations to 1990. 2 later devices descend from it.
- Decided
- Jan 25, 2022
- Review
- 617 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K894595 (1990). 30 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK100850 Cowell Implant SystemCowellmedi Co., Ltd. · 2010
- 1 generation backK132242 Inno Sla Submerged Implant SystemCowellmedi Co., Ltd. · 2013
- This deviceK201323 INNO SLA Submerged Implant SystemCowellmedi Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 7 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 6 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 5 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 4 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK100850 Cowell Implant SystemCowellmedi Co., Ltd. · 2010
- 1 generation backK132242 Inno Sla Submerged Implant SystemCowellmedi Co., Ltd. · 2013
- This deviceK201323 INNO SLA Submerged Implant SystemCowellmedi Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −7 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −6 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −5 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −4 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −2 | K100850 | Cowell Implant System | Cowellmedi Co., Ltd. | 2010 | — |
| −1 | K132242 | Inno Sla Submerged Implant System | Cowellmedi Co., Ltd. | 2013 | — |
| 0 (this device) | K201323 | INNO SLA Submerged Implant System | Cowellmedi Co., Ltd. | 2022 | — |
| +1 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +1 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K132242 | Inno Sla Submerged Implant SystemSummary page 4…• Classification regulation: 21CFR872.3630 4. Predicate Device: • Primary Predicate Device: INNO SLA Submerged Implant System by Cowellmedi Co., Ltd. (K132242) • Reference Predicate Device: Locator Implant Anchor Abutment for Endosseous Dental Implant by Zest Anchors,… | 2013 |
| * | K072878 | Modification to: Locator Implant AnchorSummary page 4…Cowellmedi Co., Ltd. (K132242) • Reference Predicate Device: Locator Implant Anchor Abutment for Endosseous Dental Implant by Zest Anchors, Inc. (K072878) 510(k) summary 1 / 7 page 5. Description: The… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K231395 (Cowellmedi Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K132242.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The INNO SLA Submerged 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 overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
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/K201323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201323: INNO SLA Submerged 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/K201323
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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