# K034067: Zti Implants System, DRM Implants

- Pathway: 510(k) (Traditional)
- Applicant: Drm Research Laboratories, Inc.
- Decided: Mar 8, 2004 after 68 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: 2 generations back to K894595 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955281: Endosseous Dental Implant & Accessories, The Straumann Co. (1996) Summary page 1.
- K924112: Hydroxylapatite Coated Saber Tech Series I & Series II, Saber Technology, Inc. (1994) Summary page 1.
- K980442: Crystal and Crystal-Seal Implants System, Crystal Medical Technology (1998). Our reading of the summary gave K980447, FDA’s number for Depuy Motech Moss Miami Spinal System (DePuy Orthopaedics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Crystal-Seal Implants”.
- K853788: DB Precision Implant System, Driskell Bioengineering (1985) Summary page 2.
- K852802: Denar Dental Implant, Denar Corp. (1985) Summary page 2.
- K884845: Steri-Oss, Denar Corp. (1989) Summary page 2.
- K921805: Stryker Precision Dental Implant System, Stryker Instruments (1994) Summary page 2.

## Indications for use
The permanent post-type implants of this system are 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. The temporary implants are intended to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

Source page: https://510kreport.com/device/K034067
Methodology: https://510kreport.com/methodology