# K991250: Quantum Versatility Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Bioengineering, Ltd.
- Decided: Sep 20, 2001 after 891 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: 1 generation back to K820013 (1982). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820013: Titanium Implant Devices, Bofors Nobelpharma, Inc. (1982) Summary page 1.
- K830414: Titanaloy Submersible Implant System, Boehringer/Miter, Inc. (1983) Summary page 1.
- K853788: DB Precision Implant System, Driskell Bioengineering (1985) Summary page 2.
- K861426: Screw-Vent (TM) Implant/Endosseous Screw Implant, Core-Vent Corp. (1986) Summary page 2.
- K892124: Impla-Med Implant System, Impla-Med (1989) Summary page 2.
- K852802: Denar Dental Implant, Denar Corp. (1985) Summary page 2.
- K884845: Steri-Oss, Denar Corp. (1989) Summary page 2.
- K891346: Artech Type SS Submerged Screw Implant, Artech Corp. (1989) Summary page 2.
- K895267: Artech Type SS-HA Submerged Screw Implant, Artech Corp. (1990) Summary page 2.
- K924112: Hydroxylapatite Coated Saber Tech Series I & Series II, Saber Technology, Inc. (1994) Summary page 1.
- K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 2.
- K974401: 4.0MM Simpler One Threaded Dental Implant, Vancouver Implant Resources, Inc. (1998) Summary page 2.

## Most influential descendants
- K112279: Quantum Dental Implant System (2012), 1 descendant of its own
- K130787: Quantum Dental Implant System (2013), 0 descendants of its own

## Indications for use
This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Source page: https://510kreport.com/device/K991250
Methodology: https://510kreport.com/methodology