510(k) · Cleared
ClearedDIMPLO Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DIMPLO, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 22, 2025 as substantially equivalent to K181138 (Neobiotech Co., Ltd., 2018) and 12 other predicates after a 209-day review. Its family tree reaches back 19 generations to 1996.
- Decided
- Dec 22, 2025
- Review
- 209 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 19 generations to K960026 (1996). 481 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations between
- 3 generations backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- 2 generations backK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- 1 generation backK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- This deviceK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
Show all 19 generations
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 18 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 17 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 16 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 12 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 11 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 10 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 9 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 8 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 7 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 6 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 5 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 4 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 3 generations backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- 2 generations backK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- 1 generation backK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- This deviceK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −18 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −12 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −11 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −10 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −9 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −8 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −7 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −6 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −5 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −3 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| −2 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| −1 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| 0 (this device) | 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 | 15 | 0 |
| 1995 | 17 | 0 |
| 1996 | 18 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 13 | 0 |
| 2000 | 12 | 0 |
| 2001 | 19 | 0 |
| 2002 | 20 | 0 |
| 2003 | 20 | 0 |
| 2004 | 21 | 0 |
| 2005 | 20 | 0 |
| 2006 | 30 | 0 |
| 2007 | 32 | 0 |
| 2008 | 31 | 0 |
| 2009 | 24 | 0 |
| 2010 | 21 | 0 |
| 2011 | 16 | 0 |
| 2012 | 18 | 0 |
| 2013 | 14 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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? (13)
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 |
|---|---|---|---|
| * | K181138 | IS-III active SystemSummary page 5…Panel: Dental - Regulation Number: 21 CFR 872.3640 - Device Class: Class II III. PREDICATE DEVICE 1. Primary Predicate (Submission Number / Applicant / Trade Name) - K181138 / Neobiotech Co., Ltd. / IS-III active System 2. Predicate/Reference Device (Submission Number / Applicant / Trade Name) - K1619… | 2018 |
| * | K161987 | UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - SuprastructureSummary page 5…on Number / Applicant / Trade Name) - K181138 / Neobiotech Co., Ltd. / IS-III active System 2. Predicate/Reference Device (Submission Number / Applicant / Trade Name) - K161987 / UF(II) Narrow Implant System / DIO Corporation - K141457 / DENTIUM CO. LTD. / DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS - K231… | 2017 |
| * | K141457 | Dentium Implantium and Superline AbutmentsSummary page 5…Co., Ltd. / IS-III active System 2. Predicate/Reference Device (Submission Number / Applicant / Trade Name) - K161987 / UF(II) Narrow Implant System / DIO Corporation - K141457 / DENTIUM CO. LTD. / DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS - K231426 / HOOWON EDI Co., Ltd. / 8palnt Implant System - K16168… | 2014 |
| * | K231426 | 8plant Implant SystemSummary page 5…n Number / Applicant / Trade Name) - K161987 / UF(II) Narrow Implant System / DIO Corporation - K141457 / DENTIUM CO. LTD. / DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS - K231426 / HOOWON EDI Co., Ltd. / 8palnt Implant System - K161689 / OSSTEM Implant Co., Ltd. / OSSTEM Implant System - Abutment - K223924… | 2024 |
| * | K161689 | OSSTEM Implant System - AbutmentSummary page 5…row Implant System / DIO Corporation - K141457 / DENTIUM CO. LTD. / DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS - K231426 / HOOWON EDI Co., Ltd. / 8palnt Implant System - K161689 / OSSTEM Implant Co., Ltd. / OSSTEM Implant System - Abutment - K223924 / Ossvis Co., Ltd. / LW Implant System - K231753 / Oneday… | 2017 |
| * | K223924 | LW Implant SystemSummary page 5…IUM IMPLANTIUM AND SUPERLINE ABUTMENTS - K231426 / HOOWON EDI Co., Ltd. / 8palnt Implant System - K161689 / OSSTEM Implant Co., Ltd. / OSSTEM Implant System - Abutment - K223924 / Ossvis Co., Ltd. / LW Implant System - K231753 / Oneday Biotech Co., Ltd. / Oneday Implant Abutment - K231411 / Cowellmedi Co.,… | 2023 |
| * | K231753 | Oneday Implant AbutmentSummary page 5…/ HOOWON EDI Co., Ltd. / 8palnt Implant System - K161689 / OSSTEM Implant Co., Ltd. / OSSTEM Implant System - Abutment - K223924 / Ossvis Co., Ltd. / LW Implant System - K231753 / Oneday Biotech Co., Ltd. / Oneday Implant Abutment - K231411 / Cowellmedi Co., Ltd. / INNO SLA Submerged Hybrid Ti-Base System… | 2024 |
| * | K231411 | INNO SLA Submerged Hybrid Ti-Base SystemSummary page 5…EM Implant Co., Ltd. / OSSTEM Implant System - Abutment - K223924 / Ossvis Co., Ltd. / LW Implant System - K231753 / Oneday Biotech Co., Ltd. / Oneday Implant Abutment - K231411 / Cowellmedi Co., Ltd. / INNO SLA Submerged Hybrid Ti-Base System - K220253 / DIO Corporation / Eco Abutment, Multiunit Abutment… | 2023 |
| * | K220253 | Eco Abutment, Multiunit AbutmentSummary page 5…o., Ltd. / LW Implant System - K231753 / Oneday Biotech Co., Ltd. / Oneday Implant Abutment - K231411 / Cowellmedi Co., Ltd. / INNO SLA Submerged Hybrid Ti-Base System - K220253 / DIO Corporation / Eco Abutment, Multiunit Abutment - K210117 / Paltop Advanced Dental Solutions, Ltd / Paltop Narrow Implant -… | 2023 |
| * | K210117 | Paltop Narrow ImplantSummary page 5…d. / Oneday Implant Abutment - K231411 / Cowellmedi Co., Ltd. / INNO SLA Submerged Hybrid Ti-Base System - K220253 / DIO Corporation / Eco Abutment, Multiunit Abutment - K210117 / Paltop Advanced Dental Solutions, Ltd / Paltop Narrow Implant - K231395 / Cowellmedi Co., Ltd. / INNO SLA Submerged Narrow Impl… | 2021 |
| * | K231395 | INNO SLA Submerged Narrow Implant SystemSummary page 5…ubmerged Hybrid Ti-Base System - K220253 / DIO Corporation / Eco Abutment, Multiunit Abutment - K210117 / Paltop Advanced Dental Solutions, Ltd / Paltop Narrow Implant - K231395 / Cowellmedi Co., Ltd. / INNO SLA Submerged Narrow Implant System - K201323 / Cowellmedi Co., Ltd. / Sonator Abutment for INNO SL… | 2023 |
| * | K201323 | INNO SLA Submerged Implant SystemSummary page 5…ultiunit Abutment - K210117 / Paltop Advanced Dental Solutions, Ltd / Paltop Narrow Implant - K231395 / Cowellmedi Co., Ltd. / INNO SLA Submerged Narrow Implant System - K201323 / Cowellmedi Co., Ltd. / Sonator Abutment for INNO SLA Submerged Implant System - K161713 / Dentium Co., Ltd / Dentium CAD/CAM Ab… | 2022 |
| * | K161713 | Dentium CAD/CAM AbutmentsSummary page 5…t - K231395 / Cowellmedi Co., Ltd. / INNO SLA Submerged Narrow Implant System - K201323 / Cowellmedi Co., Ltd. / Sonator Abutment for INNO SLA Submerged Implant System - K161713 / Dentium Co., Ltd / Dentium CAD/CAM Abutments… | 2016 |
| † | K123664 | Incoris ZI | 2013 |
| † | K100756 | MALTA | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 11 companies; a new generation was cleared every 11 months on median.
- 57 of the 481 ancestors have a recall of any class.
- 10 other devices also cite its predicate K181138.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading…
Read the full statement (126 words)
The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved.
- Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only.
- Ø5.0 mm and larger implants are intended for delayed loading in the molar region.
All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251605: DIMPLO 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/K251605
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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