# K970572: Dual Integrator Dental Implant Accessories Parallel Pin, Depth Gage, and Surgical Ratchet

- Pathway: 510(k) (Traditional)
- Applicant: Implant Integration Systems, Inc.
- Decided: Jan 16, 1998 after 336 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)
- K904707: BC 1208 Implant, Threaded External Hex, Minimatic Implant Technology (1991) Summary page 1.
- K902911: Titanium/Stainless Steel Instruments, Impla-Med (1990) Summary page 1.
- K903115: DG-1109 Depth Gage, Minimatic Implant Technology (1990) Summary page 1.
- K874590: Innovative Implants and Cover Screws, Implant Innovations International, Inc. (1988) Summary page 1.

## Indications for use
This product is designed for use in the placement of the “Dual Integrator” Dental Implant (K944225). The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the “Dual Integrator” Dental Implant into the surgical site. These products along with the “Dual Integrator” Dental Implant make up the total system of tooth replacement by Implant Integration Systems.

Source page: https://510kreport.com/device/K970572
Methodology: https://510kreport.com/methodology