# K112279: Quantum Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Bioengineering, Ltd.
- Decided: May 4, 2012 after 269 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: 9 generations back to K894595 (1990). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011223: Quantum Versatility (QVS) Dental Implant System, Paxmed International (2001)
- K002241: Quantum Versatility (QVS) Dental Implant System, Quantum Bioengineering, Ltd. (2001) Summary page 2.
- K991250: Quantum Versatility Implant System, Quantum Bioengineering, Ltd. (2001) Summary page 2.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 2.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 2.
- K010185: 6.0 X 5.7MM Dental Implant, Bicon, Inc. (2002) Summary page 3.
- K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 2.

## Most influential descendants
- K130787: Quantum Dental Implant System (2013), 0 descendants of its own

## Indications for use
Quantum TM, Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Quantum Dental Implant System abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants, or when using any 5 mm or 6 mm length implant.

Source page: https://510kreport.com/device/K112279
Methodology: https://510kreport.com/methodology