510(k) · Cleared
ClearedTiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 10, 2022 as substantially equivalent to K150203 (Medentika GmbH, 2015) after a 255-day review. Its family tree reaches back 14 generations to 1990. 5 later devices descend from it.
- Decided
- Nov 10, 2022
- Review
- 255 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894844 (1990). 171 ancestors in all, the oldest K871863 (1987). 5 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations between
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK220562 TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK223663 SIMDA AbutmentSimda Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252320 SIMDA AbutmentsSimda Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240725 PreXolid CAD/CAM abutmentsEclectic Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK234142 TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK232271 SIMDA abutmentSimda Co., Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 12 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 11 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 10 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 9 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 8 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 7 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 6 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 5 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 4 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK220562 TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K223663SIMDA AbutmentSimda Co., Ltd. · 2023 · cites it directly2descendants
- K252320SIMDA AbutmentsSimda Co., Ltd. · 2025 · 2 generations on0descendants
- K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd. · 2024 · cites it directly0descendants
- K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd. · 2024 · cites it directly0descendants
- K232271SIMDA abutmentSimda Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −13 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −12 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −11 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −10 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −9 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −8 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −7 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −6 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −5 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −4 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −3 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −1 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| 0 (this device) | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022 | — |
| +1 | K223663 | SIMDA Abutment | Simda Co., Ltd. | 2023 | — |
| +2 | K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025 | — |
| +1 | K240725 | PreXolid CAD/CAM abutments | Eclectic Co., Ltd. | 2024 | — |
| +1 | K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2024 | — |
| +2 | K232271 | SIMDA abutment | Simda Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K150203 | Medentika CAD/CAM AbutmentsSummary page 4…ode NHA • Classification regulation Class II, 21 CFR 872.3630 4. Predicate Device • Primary Predicate Device: K150203 Medentika CAD/CAM Abutments • Reference Device: K122231 XPEED AnyRidge Internal Implant System… | 2015 |
| † | K122231 | Xpeed Any Ridge Internal Implant System | 2012 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K150537 | MiNi Internal Implant System | 2015 |
| † | K171622 | Dentium Ti-Base | 2018 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K173374 | TSV BellaTek Encode Healing Abutments | 2017 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
What descends from it? (5)
3 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?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 18 of the 171 ancestors have a recall of any class.
- Of its descendants, K223663 (Simda Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K150203.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220562: TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220562
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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