510(k) · Cleared

Cleared

Dentatus Mti Modular Transitional Implants and Prosthetic System

K980620510(k) TraditionalCleared May 15, 199886-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

Dentatus USA, Ltd. · DZE Implant, Endosseous, Root-Form

Cleared on May 15, 1998 as substantially equivalent to K972351 (Sendax Mdic Management, Inc., 1997) and 10 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1978. 322 later devices descend from it.

Decided: May 15, 1998
Review: 86 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 11

Its longest line of descent runs back 1 generation to K781060 (1978). 11 ancestors in all. 322 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK781060 Monoject Endosseous Dental ImplantSherwood Medical Industries · 1978
This deviceK980620 Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd. · 1998
Descendant · cites it directly · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
Descendant · 2 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
Descendant · 3 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
Descendant · 2 generations on · 312 of its ownK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
Descendant · 3 generations on · 211 of its ownK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · Recalled

Showing 5 of 322 descendants. See all descendants

Descendants cleared per year

2002high 40 (2024) · low 0 (2006)2026

Most influential descendants

Showing 5 of 322 · See all

K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · cites it directly319descendants
K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 2 generations on318descendants
K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 3 generations on317descendants
K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005 · 2 generations on312descendants
K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · 3 generations on211descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K781060	Monoject Endosseous Dental Implant	Sherwood Medical Industries	1978	—
0 (this device)	K980620	Dentatus Mti Modular Transitional Implants and Prosthetic System	Dentatus USA, Ltd.	1998	—
+1	K030614	3I Dental Implants	Implant Innovations, Inc.	2003	—
+2	K041402	Modification to Osseotite NT Certain Implants	Implant Innovations, Inc.	2004	—
+3	K051189	Prevail Dental Implants	Implant Innovations, Inc.	2005	—
+2	K051461	3I Osseotite Dental Implants	Implant Innovations, Inc.	2005	—
+3	K063286	Osseotite; Osseotite NT; XP; TG Osseotite	Implant Innovations, Inc.	2007	5

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1985	1	0
1986	1	0
1989	3	0
1990	1	0
1992	2	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2005	2	0
2007	6	0
2008	7	0
2009	2	0
2010	1	0
2011	6	0
2012	4	0
2013	8	0
2014	11	0
2015	12	0
2016	14	0
2017	14	0
2018	13	0
2019	18	0
2020	19	0
2021	19	0
2022	31	0
2023	32	0
2024	40	0
2025	38	0
2026	22	0

FIG. 1 — Lineage of K980620, 1978–2026Source: 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

Get a 510(k) Report

What was it cleared against? (11)

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
*	K972351	Sendax Mdi (Mini Dental Implant) Summary page 1 …ined by the FDA to be substantially equivalent to the above preamendment devices. This device is equivalent (and nearly identical) to the Sendax MDI implant cleared by K-972351. Its shape, form, composition, and usage are nearly identical to those cleared in K-972351. These devices are manufactured of hig…	Sendax Mdic Management, Inc.	1997	—
*	K820013	Titanium Implant Devices Summary page 1 …cylinder type that have been cleared under a variety of 510(k)s. Several of these are listed below. 1. Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013. 2. Sherwood, St. Louis, Mo: Monoject Endosseous Dental Implant, K-781060A. 3. Core-Vent Corp., Encino, CA: Screw-Vent Endosseo…	Bofors Nobelpharma, Inc.	1982	—
*	K781060	Monoject Endosseous Dental Implant Summary page 1 …f these are listed below. 1. Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013. 2. Sherwood, St. Louis, Mo: Monoject Endosseous Dental Implant, K-781060A. 3. Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. 4. Impla-med, Inc., Sunrise, FL: P.M.T. Surgi…	Sherwood Medical Industries	1978	—
*	K861426	Screw-Vent (TM) Implant/Endosseous Screw Implant Summary page 1 …Implant Device, K-820013. 2. Sherwood, St. Louis, Mo: Monoject Endosseous Dental Implant, K-781060A. 3. Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. 4. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K892124A, (Titanium Grade 3, ASTM F67-83); K-921854…	Core-Vent Corp.	1986	—
*	K892124	Impla-Med Implant System Summary page 1 …plant, K-781060A. 3. Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B. 4. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K892124A, (Titanium Grade 3, ASTM F67-83); K-921854 and others. 5. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802;…	Impla-Med	1989	—
*	K921854	Impla-Med Hex Screw Implants, 18 and 20 MM Summary page 1 …, CA: Screw-Vent Endosseous Implants, K-861426, A, B. 4. Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K892124A, (Titanium Grade 3, ASTM F67-83); K-921854 and others. 5. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. . Artech, Inc.…	Impla-Med	1992	—
*	K852802	Denar Dental Implant Summary page 1 …L: P.M.T. Surgical Implant Components, K892124A, (Titanium Grade 3, ASTM F67-83); K-921854 and others. 5. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. . Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. . Odontit, SA, B…	Denar Corp.	1985	—
*	K884845	Steri-Oss Summary page 1 …mponents, K892124A, (Titanium Grade 3, ASTM F67-83); K-921854 and others. 5. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. . Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. . Odontit, SA, Buenos Aires, Argentina: Osseo…	Denar Corp.	1989	—
*	K891346	Artech Type SS Submerged Screw Implant Summary page 1 …. 5. Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. . Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. . Odontit, SA, Buenos Aires, Argentina: Osseointegrated Implants System, K-915375. o <@ 20 X. Brief…	Artech Corp.	1989	—
*	K895267	Artech Type SS-HA Submerged Screw Implant Summary page 1 …-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. . Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. . Odontit, SA, Buenos Aires, Argentina: Osseointegrated Implants System, K-915375. o <@ 20 X. Brief Literature…	Artech Corp.	1990	—
*	K915375	Odontit Osseointegrated Implants System Summary page 1 …, K-884845. . Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267. . Odontit, SA, Buenos Aires, Argentina: Osseointegrated Implants System, K-915375. o <@ 20 X. Brief Literature Review: Detailed literature surveys were made of the typical endosseous implant in…	Odontit Systeme	1992	—

Also cleared against K972351: 7 other devices →

What descends from it? (322)

See all 322

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030614	3I Dental Implants	Implant Innovations, Inc.	2003	319
K072917	JJG Evolution Orthodontic Implant System	Odontit S.A.	2008	0
K021915	Transitional Implants	Intra-Lock International	2002	0

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?

None of the 11 ancestors has a recall.
Of its descendants, K030614 (Implant Innovations, Inc., 2003) has gone furthest, with 319 descendants of its own.
7 other devices also cite its predicate K972351.

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?

Intended to be 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.

Examples:

Support anchors for temporary restorations during the healing and osseointegration process of permanent implants.

Immediate loading temporary abutments for repairing failing tooth and implant suported restorations.

Transitional supports for immediate replacement of missing teeth.

Provide assistance in case planning, implant position alignments, and interim anchor foundations.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980620 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980620: Dentatus Mti Modular Transitional Implants and Prosthetic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980620

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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