510(k) · Cleared
ClearedKisses Plus Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Achimhai Medical Corporation · NHA Abutment, Implant, Dental, Endosseous
Cleared on Aug 6, 2021 as substantially equivalent to K072570 (Nobel Biocare AB, 2007) and 2 other predicates after a 557-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Aug 6, 2021
- Review
- 557 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K894595 (1990). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- 1 generation backK161416 Multi-unit Abutment PlusNobel Biocare AB · 2017
- This deviceK200193 Kisses Plus Implant SystemAchimhai Medical Corporation · 2021
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- 1 generation backK161416 Multi-unit Abutment PlusNobel Biocare AB · 2017
- This deviceK200193 Kisses Plus Implant SystemAchimhai Medical Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −2 | K072570 | Nobelactive Multi Unit Abutment | Nobel Biocare AB | 2007 | 1 |
| −1 | K161416 | Multi-unit Abutment Plus | Nobel Biocare AB | 2017 | — |
| 0 (this device) | K200193 | Kisses Plus Implant System | Achimhai Medical Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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 30.7 · 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? (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 |
|---|---|---|---|
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 4…de: NHA • Classification regulation: 21CFR 872.3630 4. Predicate Device: • Primary Predicate Device: NobelActive Multi Unit Abutment by Nobel Biocare AB (K072570) • Reference Predicate Device: Multi Unit Abutment Plus by Nobel Biocare AB (K161416) SimpleLine II Abutme… | 2007 |
| * | K161416 | Multi-unit Abutment PlusSummary page 4…te Device: NobelActive Multi Unit Abutment by Nobel Biocare AB (K072570) • Reference Predicate Device: Multi Unit Abutment Plus by Nobel Biocare AB (K161416) SimpleLine II Abutment System by Dentium (K112045) Biogensis Implant System-Kisses by Biogenesis Co., Ltd. (K142… | 2017 |
| * | K112045 | Simpleline II Abutment SystemSummary page 4…iocare AB (K072570) • Reference Predicate Device: Multi Unit Abutment Plus by Nobel Biocare AB (K161416) SimpleLine II Abutment System by Dentium (K112045) Biogensis Implant System-Kisses by Biogenesis Co., Ltd. (K142813) Kisses Plus Implant System by ACHIMHAI Medical… | 2012 |
| † | K142813 | Biogensis Implant System-Kisses | 2015 |
| † | K172630 | Kisses Plus Implant System | 2018 |
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 31 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 29 ancestors have a recall of any class.
- 17 other devices also cite its predicate K072570.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Kisses Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed 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/K200193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200193: Kisses Plus Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200193
Report an extraction error
Are you the manufacturer?
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