# K093975: Simpler Toadstool Abutment, Model S19000-S19009

- Pathway: 510(k) (Traditional)
- Applicant: Pan Global Implant
- Decided: Jun 4, 2010 after 162 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891613 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051636: Camlog Dental Implant Abutments, Healing Caps, and Accessories, Altatec GmbH (2006) Summary page 1.
- K990277: O-Ring Abutment, BioHorizons Implant Systems, Inc. (1999) Summary page 1.
- K891613: Overdenture Attachment, Implant Innovations International, Inc. (1989) Summary page 1.

## Cited in the summary but 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K093975
Methodology: https://510kreport.com/methodology