510(k) · Cleared
ClearedMis Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mis - Implant Technologies, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 9, 2004 as substantially equivalent to K022009 (Implant Innovations, Inc., 2002) and 2 other predicates after a 72-day review. Its family tree reaches back 4 generations to 1993. 218 later devices descend from it.
- Decided
- Jun 9, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K925765 (1993). 29 ancestors in all, the oldest K874590 (1988). 218 later devices descend from it, 22 citing it directly.
- Root · 4 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 3 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 2 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 1 generation backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- This deviceK040807 Mis Dental Implant SystemMis - Implant Technologies, Ltd. · 2004
- Descendant · cites it directly · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 2 generations on · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- Descendant · 3 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 4 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- Descendant · 4 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
Showing 5 of 218 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 218 · See all- K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly187descendants
- K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · 2 generations on141descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 3 generations on127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 4 generations on123descendants
- K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 4 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −3 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −2 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −1 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| 0 (this device) | K040807 | Mis Dental Implant System | Mis - Implant Technologies, Ltd. | 2004 | — |
| +1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +2 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| +3 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +4 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| +4 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 18 | 0 |
| 2021 | 16 | 0 |
| 2022 | 21 | 0 |
| 2023 | 19 | 0 |
| 2024 | 20 | 0 |
| 2025 | 28 | 0 |
| 2026 | 15 | 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? (3)
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 |
|---|---|---|---|
| * | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsSummary page 2…10-2 3. Predicate Devices - 3i Dental Implant System from Implant Innovations Ltd, Palm Beach Gardens, FL, cleared under 510(k) no. K022009 (for two stage implants) 3i Dental Implant Accessories from Implant Innovations Ltd, Palm Beach Gardens, FL, cleared u… | 2002 |
| * | K022113 | 3I Dental Implant AccessoriesSummary page 2…nder 510(k) no. K022009 (for two stage implants) 3i Dental Implant Accessories from Implant Innovations Ltd, Palm Beach Gardens, FL, cleared under 5 10(k) no. K022113 (for accessories) ITI Dental Implant System from Straumann USA, Waltham, MA, cleared under 510(k) no. K030007 (for one… | 2002 |
| * | K030007 | Iti Dental Implant SystemSummary page 2…each Gardens, FL, cleared under 5 10(k) no. K022113 (for accessories) ITI Dental Implant System from Straumann USA, Waltham, MA, cleared under 510(k) no. K030007 (for one stage implants) 4. Description of the Device - The MIS Dental Implant System consists of one and two stage impla… | 2003 |
What descends from it? (218)
See all 21822 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063364 | Alpha Bio Dental Implant System | 2007 | 187 |
| K112440 | AB Dental Devices Implants and Accessories | 2012 | 36 |
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
| K140440 | Noris Medical Dental Implants System | 2014 | 14 |
| K180282 | MIS Internal Hex Dental Implant System | 2018 | 11 |
| K112795 | Paltop Dental Implant System | 2012 | 11 |
| K172225 | Atlantis Abutment for MIS Implant | 2017 | 8 |
| K180465 | Provata Implant System | 2018 | 2 |
| K133362 | SGS Dental Implant | 2014 | 2 |
| K112162 | Conical Connection Implants | 2012 | 2 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K063364 (Alpha-Bio Tec, Ltd., 2007) has gone furthest, with 187 descendants of its own.
- 12 other devices also cite its predicate K022009.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MIS Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040807: Mis 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/K040807
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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