510(k) · Cleared
ClearedKat Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kat Implants, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 2, 2009 as substantially equivalent to K982925 (Impladent, Ltd., 1999) and 4 other predicates after a 66-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- Feb 2, 2009
- Review
- 66 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K982925 (1999). 5 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK982925 Laminoss Dental ImplantImpladent, Ltd. · 1999
- This deviceK083544 Kat Implant SystemKat Implants, LLC · 2009
- Descendant · cites it directly · 3 of its ownK101201 Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0…Kat Implants, LLC · 2011
- Descendant · cites it directly · 1 of its ownK122664 Zuga Dental Implant SystemZuga Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK112758 Kat Implants System One-Piece Implants 2.5X10Kat Implants, LLC · 2012
Most influential descendants
Showing 4 of 4 · See all- K101201Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model…Kat Implants, LLC · 2011 · cites it directly3descendants
- K122664Zuga Dental Implant SystemZuga Medical, Inc. · 2013 · cites it directly1descendant
- K171197Zuga Dental Implant SystemZuga Medical, Inc. · 2018 · cites it directly0descendants
- K112758Kat Implants System One-Piece Implants 2.5X10Kat Implants, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982925 | Laminoss Dental Implant | Impladent, Ltd. | 1999 | — |
| 0 (this device) | K083544 | Kat Implant System | Kat Implants, LLC | 2009 | — |
| +1 | K101201 | Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0… | Kat Implants, LLC | 2011 | — |
| +1 | K122664 | Zuga Dental Implant System | Zuga Medical, Inc. | 2013 | — |
| +1 | K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018 | — |
| +1 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K982925 | Laminoss Dental ImplantSummary page 2…devices to which the equivalence is claimed [8 07.92(a)(3)]: Predicate device: LaminOss® Osteocompressive Dental System Applicant: Irnpladent Inc. (USA) 510(k) number: K982925 Predicate device: Bicon Dental Implant 4.5 x 6.5mm Applicant: Bicon Inc. (USA) 510(k) number: K050712 Predicate device: IMTEC S… | 1999 |
| * | K050712 | 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental ImplantSummary page 2…sive Dental System Applicant: Irnpladent Inc. (USA) 510(k) number: K982925 Predicate device: Bicon Dental Implant 4.5 x 6.5mm Applicant: Bicon Inc. (USA) 510(k) number: K050712 Predicate device: IMTEC Sedax MDI 1.8mm Applicant: IMTEC Corporation (USA) 510(k) number: K031106 Predicate device: OsseoSpeed… | 2005 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 2…Dental Implant 4.5 x 6.5mm Applicant: Bicon Inc. (USA) 510(k) number: K050712 Predicate device: IMTEC Sedax MDI 1.8mm Applicant: IMTEC Corporation (USA) 510(k) number: K031106 Predicate device: OsseoSpeed 4.0S-6mm Applicant: Astra Tech Inc. (USA) 510(k) number: K063779 Predicate device: OsseoSpeed Narr… | 2003 |
| * | K063779 | Osseospeed 4.0S-6MM, Model 24619Summary page 2…e: IMTEC Sedax MDI 1.8mm Applicant: IMTEC Corporation (USA) 510(k) number: K031106 Predicate device: OsseoSpeed 4.0S-6mm Applicant: Astra Tech Inc. (USA) 510(k) number: K063779 Predicate device: OsseoSpeed Narrow Applicant: Astra Tech Inc. (USA) 510(k) number: K080396 KAT Dental Implant System ha… | 2007 |
| * | K080396 | Osseospeed NarrowSummary page 2…device: OsseoSpeed 4.0S-6mm Applicant: Astra Tech Inc. (USA) 510(k) number: K063779 Predicate device: OsseoSpeed Narrow Applicant: Astra Tech Inc. (USA) 510(k) number: K080396 KAT Dental Implant System has the following similarities to the predicate devices: - Has the same intended… | 2008 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
KAT Implant 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. Immediate loading may not be appropriate in Type IV bone due to…
Read the full statement (190 words)
KAT Implant 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. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.
KAT 3.0mm implant is 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. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.
KAT 2.5mm is a self-tapping titanium alloy threaded screw indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT 2.5mm may also be used for inter-radicular transitional application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083544: Kat 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/K083544
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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