# K073645: Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM

- Pathway: 510(k) (Traditional)
- Applicant: 659543 BC, Ltd.
- Decided: Oct 21, 2008 after 300 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021045 (2002). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007) Summary page 1.
- K023705: Bicon Transitional Implant (Bti) System, Bicon, Inc. (2003) Summary page 1.

## Most influential descendants
- K083886: Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004 (2009), 2 descendants of its own
- K121281: Simpli Simpler Implant System (2013), 0 descendants of its own
- K092674: Simpler Toadstool Mini Implant (2009), 0 descendants of its own

## Indications for use
The Transitional Implants are designed for temporary use in edentulous sites. The pimary purpose is to provide provisional prosthetic devices to protect the permanent implants firan premature loading during the healing period. They are used to support bridges and dentures. AdditIonal uses are Inter-radicular transitional applications, immediate splinting tability, fuland partial edentulism and using minimally Invasive surgical intervention The target population Isdetermined when there is inadequate bone for wider Implants as wll as for patients wishing Immediate functional loading. The transitionals are to be used In a clinical site by a qualified dentist experienced in placing dental Implamn.

Source page: https://510kreport.com/device/K073645
Methodology: https://510kreport.com/methodology