510(k) · Cleared

Cleared

Zti Implants System, DRM Implants

K034067510(k) TraditionalCleared Mar 8, 200468-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Drm Research Laboratories, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 8, 2004 as substantially equivalent to K955281 (The Straumann Co., 1996) and 6 other predicates after a 68-day review. Its family tree reaches back 2 generations to 1990.

Decided: Mar 8, 2004
Review: 68 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K894595 (1990). 19 ancestors in all, the oldest K820013 (1982). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
1 generation backK955281 Endosseous Dental Implant & AccessoriesThe Straumann Co. · 1996
This deviceK034067 Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−1	K955281	Endosseous Dental Implant & Accessories	The Straumann Co.	1996	—
0 (this device)	K034067	Zti Implants System, DRM Implants	Drm Research Laboratories, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1985	2	0
1986	1	0
1989	3	0
1990	1	0
1992	3	0
1993	1	0
1994	2	0
1995	1	0
1996	1	0
1998	1	0

FIG. 1 — Lineage of K034067, 1990–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DZE device

#1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K955281	Endosseous Dental Implant & Accessories Summary page 1 …r to the Straumann ITI Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-955281 and the ITI TE TM system in general. Like many commercial implants, the ZTI devices are manufactured of high-purity (99+%) titani…	The Straumann Co.	1996	—
*	K924112	Hydroxylapatite Coated Saber Tech Series I & Series II Summary page 1 …pray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112 and the Crystal-Seal Implants of Crystal Technology, cleared under K-980447. VII. Labels and Instructions for Use are provided,…	Saber Technology, Inc.	1994	—
*	K980442	Crystal and Crystal-Seal Implants System 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”.	Crystal Medical Technology	1998	—
*	K853788	DB Precision Implant System Summary page 2 …r K-955281. Some examples of other equivalent products are: 20 Driskell Bioengineering, Westerville, OH, K-853788, DB Precision Implant Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Stryk…	Driskell Bioengineering	1985	—
*	K852802	Denar Dental Implant Summary page 2 …20 Driskell Bioengineering, Westerville, OH, K-853788, DB Precision Implant Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Stryker Instruments, Kalamazoo, MI, K-921805, Stryker Precision System.In VIII. Clinical Discussio…	Denar Corp.	1985	—
*	K884845	Steri-Oss Summary page 2 …== Driskell Bioengineering, Westerville, OH, K-853788, DB Precision Implant Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Stryker Instruments, Kalamazoo, MI, K-921805, Stryker Precision System.In VIII. Clinical Discussion and Brief Literature Review…	Denar Corp.	1989	—
*	K921805	Stryker Precision Dental Implant System Summary page 2 …-853788, DB Precision Implant Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Stryker Instruments, Kalamazoo, MI, K-921805, Stryker Precision System.In VIII. Clinical Discussion and Brief Literature Review: Endosseous implants, and especially those of…	Stryker Instruments	1994	—

Also cleared against K955281: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
None of the 19 ancestors has a recall.
2 other devices also cite its predicate K955281.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K034067 · printed Nov 4, 2026

Cite this page

510(k) Report. “K034067: Zti Implants System, DRM Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034067

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026