510(k) · Cleared
ClearedINNO SLA Submerged Narrow Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cowellmedi Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 18, 2023 as substantially equivalent to K161987 (Dio Corporation, 2017) and 11 other predicates after a 156-day review. Its family tree reaches back 18 generations to 1996. 1 later device descends from it.
- Decided
- Oct 18, 2023
- Review
- 156 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 18 generations to K960026 (1996). 457 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- 1 generation backK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- This deviceK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 2 generations backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- 1 generation backK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- This deviceK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| −1 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 14 | 0 |
| 1994 | 14 | 0 |
| 1995 | 15 | 0 |
| 1996 | 18 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 13 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 20 | 0 |
| 2003 | 19 | 0 |
| 2004 | 20 | 0 |
| 2005 | 18 | 0 |
| 2006 | 28 | 0 |
| 2007 | 32 | 0 |
| 2008 | 31 | 0 |
| 2009 | 24 | 0 |
| 2010 | 21 | 0 |
| 2011 | 15 | 0 |
| 2012 | 18 | 0 |
| 2013 | 14 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (12)
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 |
|---|---|---|---|
| * | K161987 | UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - SuprastructureSummary page 5…ass II, 21 CFR 872.3640 Classification Product Code: DZE, NHA 4. Predicate Device: • Primary Predicate Device: UF(II) Narrow Implant System (K161987) by Dio, Inc. • Reference Device: - Straumann® Ø2.9 mm Bone Level Tapered Implants (K162890) by Straumann USA,… | 2017 |
| * | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Summary page 5…• Primary Predicate Device: UF(II) Narrow Implant System (K161987) by Dio, Inc. • Reference Device: - Straumann® Ø2.9 mm Bone Level Tapered Implants (K162890) by Straumann USA, LLC - Healing Abutment for INNO SLA Submerged Implant System (K132242) by Cowellmedi Co.,… | 2017 |
| * | K132242 | Inno Sla Submerged Implant SystemSummary page 5…ce Device: - Straumann® Ø2.9 mm Bone Level Tapered Implants (K162890) by Straumann USA, LLC - Healing Abutment for INNO SLA Submerged Implant System (K132242) by Cowellmedi Co., Ltd. - Angulated Abutment for INNO SLA Submerged Implant System (K201323)… | 2013 |
| * | K201323 | INNO SLA Submerged Implant SystemSummary page 6…t for INNO SLA Submerged Implant System (K132242) by Cowellmedi Co., Ltd. - Angulated Abutment for INNO SLA Submerged Implant System (K201323) by Cowellmedi Co., Ltd. - IS-III active System (K181138) by Neobiotech Co., Ltd. - Paltop Narrow I… | 2022 |
| * | K181138 | IS-III active SystemSummary page 6…, Ltd. - Angulated Abutment for INNO SLA Submerged Implant System (K201323) by Cowellmedi Co., Ltd. - IS-III active System (K181138) by Neobiotech Co., Ltd. - Paltop Narrow Implant (K210117) by Paltop Advanced Dental Solutions, Ltd - Superli… | 2018 |
| * | K210117 | Paltop Narrow ImplantSummary page 6…ubmerged Implant System (K201323) by Cowellmedi Co., Ltd. - IS-III active System (K181138) by Neobiotech Co., Ltd. - Paltop Narrow Implant (K210117) by Paltop Advanced Dental Solutions, Ltd - Superline (K160965) by Dentium Co., Ltd. - Oneplant Dental Implan… | 2021 |
| * | K161689 | OSSTEM Implant System - AbutmentSummary page 13…Substantial Equivalence Discussion The subject device (Multi S Abutment) is substantially equivalent to the predicate device (Multi Abutment, K161689). The subject device and the predicate device have the same internal implant interface connections, are made of Ti-6Al-4V EL… | 2017 |
| * | K160965 | SuperLineSummary page 6…- IS-III active System (K181138) by Neobiotech Co., Ltd. - Paltop Narrow Implant (K210117) by Paltop Advanced Dental Solutions, Ltd - Superline (K160965) by Dentium Co., Ltd. - Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd. - URIS OMNI Na… | 2017 |
| * | K081748 | Oneplant Dental Implant SystemSummary page 6…Paltop Narrow Implant (K210117) by Paltop Advanced Dental Solutions, Ltd - Superline (K160965) by Dentium Co., Ltd. - Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd. - URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Korea Co., Ltd.… | 2009 |
| * | K200817 | URIS OMNI Narrow System & ProstheticSummary page 6…rline (K160965) by Dentium Co., Ltd. - Oneplant Dental Implant System (K081748) by WARANTEC Implant Co., Ltd. - URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Korea Co., Ltd. - Magicore Solid Abutment (K201981) by InnoBioSurg Co., Ltd. - Multi Unit Tem… | 2020 |
| * | K201981 | Magicore SystemSummary page 6…em (K081748) by WARANTEC Implant Co., Ltd. - URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Korea Co., Ltd. - Magicore Solid Abutment (K201981) by InnoBioSurg Co., Ltd. - Multi Unit Temporary Cylinder (K210903) by Neobiotech Co., Ltd - BTI Interna Narr… | 2020 |
| * | K210903 | IS Multi Unit Abutment SystemSummary page 6…m & Prosthetic (K200817) by TruAbutment Korea Co., Ltd. - Magicore Solid Abutment (K201981) by InnoBioSurg Co., Ltd. - Multi Unit Temporary Cylinder (K210903) by Neobiotech Co., Ltd - BTI Interna Narrow/Plus Dental Implant System UnicCa (K211952) by B.T.I. Biotechnology… | 2021 |
| † | K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | 2022 |
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 |
|---|---|---|---|
| K251605 | DIMPLO Implant System | 2025 | 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 27 years and passes through 10 companies; a new generation was cleared every 11 months on median.
- 55 of the 457 ancestors have a recall of any class.
- Of its descendants, K251605 (DIMPLO, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161987.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
- The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading.
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/K231395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231395: INNO SLA Submerged Narrow Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231395
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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