510(k) · Cleared

Cleared

Simpler Toadstool Abutment, Model S19000-S19009

K093975510(k) TraditionalCleared Jun 4, 2010162-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

Pan Global Implant · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jun 4, 2010 as substantially equivalent to K051636 (Altatec GmbH, 2006) and 2 other predicates after a 162-day review. Its family tree reaches back 1 generation to 1989.

Decided: Jun 4, 2010
Review: 162 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K891613 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK891613 Overdenture AttachmentImplant Innovations International, Inc. · 1989 · Recalled
This deviceK093975 Simpler Toadstool Abutment, Model S19000-S19009Pan Global Implant · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891613	Overdenture Attachment	Implant Innovations International, Inc.	1989	6
0 (this device)	K093975	Simpler Toadstool Abutment, Model S19000-S19009	Pan Global Implant	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2006	1	0

FIG. 1 — Lineage of K093975, 1989–2010Source: 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 30.7 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K051636	Camlog Dental Implant Abutments, Healing Caps, and Accessories Summary page 1 …d devices include the use of a ball abutment, 0 rings, keepers, compatibility with the company's implants, intended use, indications for use and safety standards. Camlog K051636, Bicon K8353733, Biomet and BioHorizons K990277, Implant Innovations K891613 are all approved 0 ring abutment systems which have…	Altatec GmbH	2006	—
Kept off the family tree	K835373	Bicon Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …de the use of a ball abutment, 0 rings, keepers, compatibility with the company's implants, intended use, indications for use and safety standards. Camlog K051636, Bicon K8353733, Biomet and BioHorizons K990277, Implant Innovations K891613 are all approved 0 ring abutment systems which have proven safe and…
*	K990277	O-Ring Abutment Summary page 1 …rings, keepers, compatibility with the company's implants, intended use, indications for use and safety standards. Camlog K051636, Bicon K8353733, Biomet and BioHorizons K990277, Implant Innovations K891613 are all approved 0 ring abutment systems which have proven safe and effective and substantially equi…	BioHorizons Implant Systems, Inc.	1999	—
*	K891613	Overdenture Attachment Summary page 1 …with the company's implants, intended use, indications for use and safety standards. Camlog K051636, Bicon K8353733, Biomet and BioHorizons K990277, Implant Innovations K891613 are all approved 0 ring abutment systems which have proven safe and effective and substantially equivalent to the Simpler Toadsto…	Implant Innovations International, Inc.	1989	6
†	K092674	Simpler Toadstool Mini Implant	Pan Global Implant	2009	—
†	K974403	3.25MM Simpler One Pushin Dental Implant	Vancouver Implant Resources, Inc.	1998	—
†	K060376	Simpler HA Threaded, ST 5002-8, Sit 5002-8, ST 5011-ST5014, ST 5021-24	Simpler Implant, Inc.	2006	—
†	K974404	4.0MM Simpler One Pushin Dental Implant	Vancouver Implant Resources, Inc.	1998	—

Also cleared against K051636: 4 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?

1 of the 3 ancestors has a recall of any class.
4 other devices also cite its predicate K051636.

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. 2010, 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?

The Simpler Toadstool Abutment consists of a pre-manufactured flattened ball which is directly screwed into a Simpler endosseous dental implant. The design allows for a lower profile height for a soft tissue supported overdenture. The prosthetic device is indicated for retention of soft tissue supported overdentures only and NOT for implant supported prostheses such as crowns and bridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093975 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093975: Simpler Toadstool Abutment, Model S19000-S19009.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093975

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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