510(k) · Cleared

Cleared

Spi Vario Angled Abutment

K111984510(k) TraditionalCleared Nov 10, 2011121-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Thommen Medical AG · NHA Abutment, Implant, Dental, Endosseous

Cleared on Nov 10, 2011 as substantially equivalent to K031747 (Thommen Medical AG, 2003) and 2 other predicates after a 121-day review. Its family tree reaches back 3 generations to 1991.

Decided: Nov 10, 2011
Review: 121 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K901927 (1991). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK901927 HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 1991
2 generations backK023645 Spi Easy Dental Implant AbutmentThommen Medical AG · 2002 · Recalled
1 generation backK031747 Spi Dental Implant AbutmentsThommen Medical AG · 2003
This deviceK111984 Spi Vario Angled AbutmentThommen Medical AG · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K901927	HA-TI (Hand-Titanium Screw) Implant	Mathys Corp. of North America	1991	—
−2	K023645	Spi Easy Dental Implant Abutment	Thommen Medical AG	2002	1
−1	K031747	Spi Dental Implant Abutments	Thommen Medical AG	2003	—
0 (this device)	K111984	Spi Vario Angled Abutment	Thommen Medical AG	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2008	1	0
2009	1	0

FIG. 1 — Lineage of K111984, 1991–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K031747	Spi Dental Implant Abutments Summary page 2 …ices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Thommen Medical AG, SPI®D Dental Implant Abutments cleared under K03 1747 Thommen Medical AG, SPI® VARI0multi Abutment cleared under K072856 Thommen Medical AG, SPI® VARIOmulti Angled Abutment cleared un…	Thommen Medical AG	2003	—
*	K072856	Spi Variomulti Abutment Summary page 2 …quivalent to pre-amendment devices: Thommen Medical AG, SPI®D Dental Implant Abutments cleared under K03 1747 Thommen Medical AG, SPI® VARI0multi Abutment cleared under K072856 Thommen Medical AG, SPI® VARIOmulti Angled Abutment cleared under K090153 The subject device and the predicate devices have the…	Thommen Medical AG	2008	—
*	K090153	Spi Variomulti Angled Abutment Summary page 2 …ant Abutments cleared under K03 1747 Thommen Medical AG, SPI® VARI0multi Abutment cleared under K072856 Thommen Medical AG, SPI® VARIOmulti Angled Abutment cleared under K090153 The subject device and the predicate devices have the same intended use, the same technological characteristics, are made of the…	Thommen Medical AG	2009	—

Also cleared against K031747: 6 other devices →

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 20 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
1 of the 6 ancestors has a recall of any class.
6 other devices also cite its predicate K031747.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007high 858 (2015) · low 1 (2007)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?

Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide Support for crowns or bridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111984 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111984: Spi Vario Angled Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111984

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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