510(k) · Cleared
ClearedSpi Customizable Gingiva Former
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thommen Medical AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 25, 2009 as substantially equivalent to K051527 (Thommen Medical AG, 2005) and 3 other predicates after a 59-day review. Its family tree reaches back 5 generations to 1991. 10 later devices descend from it.
- Decided
- Sep 25, 2009
- Review
- 59 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K901927 (1991). 9 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK901927 HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 1991
- 4 generations backK023645 Spi Easy Dental Implant AbutmentThommen Medical AG · 2002 · Recalled
- 3 generations backK031747 Spi Dental Implant AbutmentsThommen Medical AG · 2003
- 2 generations backK033346 Spi Easy Dental Implant Protective CapThommen Medical AG · 2003
- 1 generation backK051527 Spi Easy Temporary CapThommen Medical AG · 2005
- This deviceK092248 Spi Customizable Gingiva FormerThommen Medical AG · 2009
- Descendant · cites it directly · 9 of its ownK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- Descendant · 2 generations on · 4 of its ownK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- Descendant · 2 generations on · 3 of its ownK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
- Descendant · 2 generations on · 2 of its ownK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
- Descendant · 3 generations on · 1 of its ownK181266 Implantswiss Dental Implant System, Implantswiss Dental Abutment…Novodent SA · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K122988Klockner Dental Implant AbutmentsSoadco, S.L. · 2013 · cites it directly9descendants
- K151194Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016 · 2 generations on4descendants
- K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016 · 2 generations on3descendants
- K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · 2 generations on2descendants
- K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901927 | HA-TI (Hand-Titanium Screw) Implant | Mathys Corp. of North America | 1991 | — |
| −4 | K023645 | Spi Easy Dental Implant Abutment | Thommen Medical AG | 2002 | 1 |
| −3 | K031747 | Spi Dental Implant Abutments | Thommen Medical AG | 2003 | — |
| −2 | K033346 | Spi Easy Dental Implant Protective Cap | Thommen Medical AG | 2003 | — |
| −1 | K051527 | Spi Easy Temporary Cap | Thommen Medical AG | 2005 | — |
| 0 (this device) | K092248 | Spi Customizable Gingiva Former | Thommen Medical AG | 2009 | — |
| +1 | K122988 | Klockner Dental Implant Abutments | Soadco, S.L. | 2013 | — |
| +2 | K151194 | Klockner Dental Implant Abutments (II) | Soadco, S.L. | 2016 | — |
| +2 | K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016 | — |
| +2 | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
| +3 | K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K051527 | Spi Easy Temporary CapSummary page 2…le Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration. EQUIVALENCE TO MARKETED PRODUCT Predicate devices: K051527, K033346, K023645 and K031747. The SPI®Customizable Gingiva Former has the following similarities to the unmodified predicate de… | 2005 |
| * | K033346 | Spi Easy Dental Implant Protective CapSummary page 2…a Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration. EQUIVALENCE TO MARKETED PRODUCT Predicate devices: K051527, K033346, K023645 and K031747. The SPI®Customizable Gingiva Former has the following similarities to the unmodified predicate devices:… | 2003 |
| * | K023645 | Spi Easy Dental Implant AbutmentSummary page 2…is used for maintaining gingival contour and as a base for fabrication of a temporary restoration. EQUIVALENCE TO MARKETED PRODUCT Predicate devices: K051527, K033346, K023645 and K031747. The SPI®Customizable Gingiva Former has the following similarities to the unmodified predicate devices: * h… | 2002 |
| * | K031747 | Spi Dental Implant AbutmentsSummary page 2…maintaining gingival contour and as a base for fabrication of a temporary restoration. EQUIVALENCE TO MARKETED PRODUCT Predicate devices: K051527, K033346, K023645 and K031747. The SPI®Customizable Gingiva Former has the following similarities to the unmodified predicate devices: * has the same… | 2003 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122988 | Klockner Dental Implant Abutments | 2013 | 9 |
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 18 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K122988 (Soadco, S.L., 2013) has gone furthest, with 9 descendants of its own.
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?
The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092248: Spi Customizable Gingiva Former.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092248
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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