510(k) · Cleared
ClearedMostdi Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mostdi Innovations Sdn Bhd · DZE Implant, Endosseous, Root-Form
Cleared on Apr 30, 2014 as substantially equivalent to K130140 (Intra-Lock International, 2013) and 3 other predicates after a 289-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Apr 30, 2014
- Review
- 289 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K960026 (1996). 128 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 2 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 1 generation backK121707 Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012
- This deviceK132178 Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 2 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 1 generation backK121707 Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012
- This deviceK132178 Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −2 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −1 | K121707 | Lew Mdi O-Ball Collared Implant, | Park Dental Research Corp. | 2012 | — |
| 0 (this device) | K132178 | Mostdi Dental Implant System | Mostdi Innovations Sdn Bhd | 2014 | — |
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 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 13 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K130140 | Intra-Lock OP Dental Implant Cleared while this submission was under review Summary page 2…Ball implant IMTEC Sendax MDI and LComparison Implant System MDD Phus Regulatory Status Present Predicate Pradicate Predicate Predicate Application 510(k] Number X132178 K130140 K070601 K121707 X0331106 Moeterial TIBAMY ASTM F-136 * TiGAI4V ASTM F-136 TiSAMV ASTM F-136 TEAMY ASTM F-136 TIBARV ASTM F-136 On… | 2013 |
| * | K070601 | Mini Drive-Lock Dental Implant SystemSummary page 2…lant IMTEC Sendax MDI and LComparison Implant System MDD Phus Regulatory Status Present Predicate Pradicate Predicate Predicate Application 510(k] Number X132178 K130140 K070601 K121707 X0331106 Moeterial TIBAMY ASTM F-136 * TiGAI4V ASTM F-136 TiSAMV ASTM F-136 TEAMY ASTM F-136 TIBARV ASTM F-136 One Piece/… | 2007 |
| * | K121707 | Lew Mdi O-Ball Collared Implant,Summary page 2…EC Sendax MDI and LComparison Implant System MDD Phus Regulatory Status Present Predicate Pradicate Predicate Predicate Application 510(k] Number X132178 K130140 K070601 K121707 X0331106 Moeterial TIBAMY ASTM F-136 * TiGAI4V ASTM F-136 TiSAMV ASTM F-136 TEAMY ASTM F-136 TIBARV ASTM F-136 One Piece/ Two Pie… | 2012 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX Our OCR of the scanned summary read K033106, FDA’s number for Captia HSV 2 Igg Type Specific Elisa Kit (Trinity Biotech USA). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “IMTEC Sendax MDI and MDI Plus”. | 2003 |
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 18 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 14 of the 128 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. 2014, 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 Mostdi - dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal 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/K132178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132178: Mostdi Dental 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/K132178
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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