510(k) · Cleared
ClearedBluediamond Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 27, 2024 as substantially equivalent to K231967 (Megagen Implant Co., Ltd., 2023) after a 175-day review. Its family tree reaches back 15 generations to 1993.
- Decided
- Dec 27, 2024
- Review
- 175 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K925765 (1993). 218 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 11 generations between
- 3 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 2 generations backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- 1 generation backK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
- This deviceK241972 Bluediamond ImplantMegagen Implant Co., Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 14 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 13 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 12 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 11 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 10 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 9 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 8 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 7 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 6 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 5 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 4 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 3 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 2 generations backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- 1 generation backK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
- This deviceK241972 Bluediamond ImplantMegagen Implant Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −14 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −13 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −12 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −11 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −10 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −9 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −8 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −7 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −6 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −5 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −4 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −3 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| −2 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| −1 | K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023 | — |
| 0 (this device) | K241972 | Bluediamond Implant | Megagen Implant Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 8 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 15 | 0 |
| 1994 | 11 | 0 |
| 1995 | 15 | 0 |
| 1996 | 14 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 3 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (1)
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 |
|---|---|---|---|
| * | K231967 | ARi ExCon Implant SystemSummary page 5…Classification Regulation: 872.3640 • Primary Product Code: DZE 4. Predicate Device • Primary Predicate Device: K231967 - ARi ExCon Implant System • Reference Device: K182448 - BLUEDIAMOND IMPLANT System K… | 2023 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K210852 | Noris Medical Dental Implants System - Cortical | 2022 |
| † | K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | 2023 |
| † | K202942 | Straumann 4 mm Short Implants | 2021 |
| † | K213599 | SuperLine | 2022 |
| † | K200586 | Straumann TLX Implant System | 2020 |
| † | K122231 | Xpeed Any Ridge Internal Implant System | 2012 |
| † | K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | 2020 |
| † | K210161 | AnyOne Onestage Implant System | 2021 |
| † | K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | 2021 |
| † | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary… | 2024 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 26 of the 218 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 BLUEDIAMOND IMPLANT is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with…
Read the full statement (186 words)
The BLUEDIAMOND IMPLANT is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:
- Delayed loading
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
It is specifically recommended for:
- Fixed partial dentures/splinted units (one implant per unit)
- Pontic cases in combination with at least one longer implant
- Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241972: Bluediamond Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241972
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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