# K130787: Quantum Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Bioengineering, Ltd.
- Decided: Jun 13, 2013 after 84 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: 10 generations back to K894595 (1990). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112279: Quantum Dental Implant System, Quantum Bioengineering, Ltd. (2012) Summary page 2.
- K991250: Quantum Versatility Implant System, Quantum Bioengineering, Ltd. (2001) Summary page 2.
- K101849: Bicon Dental Implant System 3.0MM Bicon Dental Implant, Bicon, LLC (2010) Summary page 2.
- K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 2.

## Cited in the summary but kept off the family tree
- K002241: Quantum Versatility (QVS) Dental Implant System, Quantum Bioengineering, Ltd. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implants 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. The @3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.

Source page: https://510kreport.com/device/K130787
Methodology: https://510kreport.com/methodology