# K962610: Dual Integrator Dental Implant Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Implant Integration Systems, Inc.
- Decided: Oct 18, 1996 after 107 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 K874590 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904709: BC 1213 Healing Screw, Minimatic Implant Technology (1991) Summary page 1.
- K902434: Dia Healing Cap, Dental Imaging Assoc., Inc. (1991) Summary page 1.
- K903062: HS-1113 Healing Screw - Rev. a, Minimatic Implant Technology (1990) Summary page 1.
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.

## Indications for use
The “Dual Integrator” Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems “Dual Integrator” Dental Implant (K944225).

Source page: https://510kreport.com/device/K962610
Methodology: https://510kreport.com/methodology