510(k) · Cleared
ClearedLew Mdi O-Ball Collared Implant,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Park Dental Research Corp. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 24, 2012 as substantially equivalent to K031106 (Imtec Corp., 2003) and 4 other predicates after a 105-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Sep 24, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K960026 (1996). 86 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK121707 Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012
- Descendant · cites it directly · 0 of its ownK132178 Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK121707 Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −1 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| 0 (this device) | K121707 | Lew Mdi O-Ball Collared Implant, | Park Dental Research Corp. | 2012 | — |
| +1 | K132178 | Mostdi Dental Implant System | Mostdi Innovations Sdn Bhd | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (5)
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 |
|---|---|---|---|
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 2…e have listed five 510(k) implants systems. A detailed chart of more implant systems is included in Section 12 Element of LEW Mini 0-Ball IMTEC K031106 IMTEC K081653 Intra-Locc K070601 Intra-Lock Prismatic Comparison Implant… | 2003 |
| * | K081653 | Mdi Mii One-Piece Implant, 2.9MMSummary page 2…implants systems. A detailed chart of more implant systems is included in Section 12 Element of LEW Mini 0-Ball IMTEC K031106 IMTEC K081653 Intra-Locc K070601 Intra-Lock Prismatic Comparison Implant… | 2008 |
| * | K070601 | Mini Drive-Lock Dental Implant SystemSummary page 1…sification Name and Number: Endosseous Dental Implant (21 CFR 872.3640 OZE) Devices for Substantial Equivalence: IMTEC MDI K(031106, IMTEC MII K(081653, Intra-Lock MDi. K070601, Intra-Lock MILO K(050970, Prizmatics Inclusive K(100932 Device Description The LEW M ini 0-ball implant (M DI) isavailable with… | 2007 |
| * | K050970 | Milo Dental Implant SystemSummary page 1…Endosseous Dental Implant (21 CFR 872.3640 OZE) Devices for Substantial Equivalence: IMTEC MDI K(031106, IMTEC MII K(081653, Intra-Lock MDi. K070601, Intra-Lock MILO K(050970, Prizmatics Inclusive K(100932 Device Description The LEW M ini 0-ball implant (M DI) isavailable with a 1.5 mm gingival collar… | 2005 |
| * | K100932 | Inclusive Mini ImplantSummary page 2…ck Prismatic Comparison Implant KOS0S70 K100932 Diameter 2.0, 2.5, 3.0 1.8, 2.1, 2.4 2.9 2.0, 2.5 3.0… | 2010 |
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 |
|---|---|---|---|
| K132178 | Mostdi Dental Implant System | 2014 | 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 16 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 9 of the 86 ancestors have a recall of any class.
- Of its descendants, K132178 (Mostdi Innovations Sdn Bhd, 2014) has gone furthest, with 0 descendants of its own.
- 22 other devices also cite its predicate K031106.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Park Dental Research Corporation's LEW 0-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini 0-ball Implant may be used for inter-radicular transitional applications:
These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
The 2.0mm, 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121707: Lew Mdi O-Ball Collared Implant,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121707
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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