510(k) · Cleared
ClearedKat Implants System One-Piece Implants 2.5X10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kat Implants, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Feb 23, 2012 as substantially equivalent to K083544 (Kat Implants, LLC, 2009) and 3 other predicates after a 154-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Feb 23, 2012
- Review
- 154 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K960026 (1996). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 6 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 5 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 2 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 1 generation backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- This deviceK112758 Kat Implants System One-Piece Implants 2.5X10Kat Implants, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −7 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −5 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −2 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −1 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| 0 (this device) | K112758 | Kat Implants System One-Piece Implants 2.5X10 | Kat Implants, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083544 | Kat Implant SystemSummary page 2…ted devices to which the equivalence is claimed [807.92(a)(3)]: KAT Implants System Implants 2.5, 3.0, 3.5. 4.3 and 5.0 mm diameters Applicant: KAT Implants, LLC 510(k): K083544 KAT Implants System Implants 6.0. 7.0 and 8.0 mm diameters Applicant: KAT Implants, LLC 510(k): K101201 KAT Implants System Strai… | 2009 |
| * | K101201 | Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model…Summary page 2….5. 4.3 and 5.0 mm diameters Applicant: KAT Implants, LLC 510(k): K083544 KAT Implants System Implants 6.0. 7.0 and 8.0 mm diameters Applicant: KAT Implants, LLC 510(k): K101201 KAT Implants System Straight Abutments 4.2x6.5, 4.6x6.5 and 5,4x6.5 Applicant: KAT Implants, LLC 510(k): K101201 KAT Implants Sys… | 2011 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 2…1201 KAT Implants System Implant Abutment 4.2x6.5 Applicant: KAT Implants, LLC 510(k): K083544 IMTEC Sendlax MVDI 1.8mm Applicant: IMTEG Corporation (USA) 510(k) Number: K031106 Maximus 3.0mm Diameter Implant Applicant: Biohorizons Implant Systems, Inc. 510O(k) Number: K032351 0-ring Abutment Applicant: Bi… | 2003 |
| * | K032351 | The Maestro System 3.0MM Diameter ImplantSummary page 2…Sendlax MVDI 1.8mm Applicant: IMTEG Corporation (USA) 510(k) Number: K031106 Maximus 3.0mm Diameter Implant Applicant: Biohorizons Implant Systems, Inc. 510O(k) Number: K032351 0-ring Abutment Applicant: Biohorizons Implant Systems, Inc. 510(k) Number: K99027 Description of Devices: Like… | 2003 |
| Kept off the family tree | K990027 | FDA’s K990027 is Omnicorder, Model 464 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1999 |
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 16 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 2 of the 21 ancestors have a recall of any class.
- 3 other devices also cite its predicate K083544.
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?
KAT Implants System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implant can be placed in extraction sites or healed alveolar ridges. KAT Implants System 2.5mm implants are self-tapping titanium alloy…
Read the full statement (190 words)
KAT Implants System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implant can be placed in extraction sites or healed alveolar ridges.
KAT Implants System 2.5mm implants are self-tapping titanium alloy threaded screws indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT Implants System 2.5mm implants may also be used for inter-radicular transitional application.
KAT Implants System 3.0mm implants are indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artificial teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate.
KAT Implants System Abutments are intended to be used with KAT Implants System Dental Implants aid in prosthetic rehabilitation of the edentulous areas in maxilla and mandible.
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/K112758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112758: Kat Implants System One-Piece Implants 2.5X10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112758
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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