510(k) · Cleared
ClearedWarantec Custom Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Warantec Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 2, 2023 as substantially equivalent to K110308 (Osstem Implant Co., Ltd., 2011) and 3 other predicates after a 454-day review. Its family tree reaches back 17 generations to 1990.
- Decided
- Oct 2, 2023
- Review
- 454 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K894844 (1990). 223 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 17 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations between
- 3 generations backK171799 Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S · 2018
- 2 generations backK190299 Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2019
- 1 generation backK192457 Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2020
- This deviceK221972 Warantec Custom AbutmentWarantec Co., Ltd. · 2023
Show all 17 generations
- Root · 17 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 16 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 15 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 14 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 13 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 12 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 11 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 10 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 9 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 8 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 7 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 6 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 5 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 4 generations backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- 3 generations backK171799 Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S · 2018
- 2 generations backK190299 Elos Accurate® Customized AbutmentElos Medtech Pinol A/S · 2019
- 1 generation backK192457 Elos Accurate Customized AbutmentElos Medtech Pinol A/S · 2020
- This deviceK221972 Warantec Custom AbutmentWarantec Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −16 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −15 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −14 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −13 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −12 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −11 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −10 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −9 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −8 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −7 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −6 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −5 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −4 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| −3 | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | Elos Medtech Pinol A/S | 2018 | — |
| −2 | K190299 | Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | 2019 | — |
| −1 | K192457 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2020 | — |
| 0 (this device) | K221972 | Warantec Custom Abutment | Warantec 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 | 12 | 0 |
| 1995 | 10 | 0 |
| 1996 | 14 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 10 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 18 | 0 |
| 2003 | 13 | 0 |
| 2004 | 11 | 0 |
| 2005 | 11 | 0 |
| 2006 | 18 | 0 |
| 2007 | 13 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K110308 | Prosthetic SystemSummary page 5…lass II g) Panel : Dental 3. Predicate deivces” a) Primary Predicate Device: Prosthetic System / OSSTEM Implant Co., Ltd. / K110308 b) Reference Device: Ti-Blank / Dentium Co., Ltd. / K161713 Elos Accurate® Customized Abutment / Elos Me… | 2011 |
| * | K161713 | Dentium CAD/CAM AbutmentsSummary page 5…” a) Primary Predicate Device: Prosthetic System / OSSTEM Implant Co., Ltd. / K110308 b) Reference Device: Ti-Blank / Dentium Co., Ltd. / K161713 Elos Accurate® Customized Abutment / Elos Medtech Pinol A/S / K192457 IU Implant System / Warantec Co., Ltd.… | 2016 |
| * | K192457 | Elos Accurate Customized AbutmentSummary page 5…nt Co., Ltd. / K110308 b) Reference Device: Ti-Blank / Dentium Co., Ltd. / K161713 Elos Accurate® Customized Abutment / Elos Medtech Pinol A/S / K192457 IU Implant System / Warantec Co., Ltd. / K172345 510(k) Summary… | 2020 |
| * | K172345 | IU Implant SystemSummary page 5…Ti-Blank / Dentium Co., Ltd. / K161713 Elos Accurate® Customized Abutment / Elos Medtech Pinol A/S / K192457 IU Implant System / Warantec Co., Ltd. / K172345 510(k) Summary Page 1 of 7 4. Device descri… | 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 33 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 22 of the 223 ancestors have a recall of any class.
- 6 other devices also cite its predicate K110308.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221972: Warantec Custom Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221972
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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