510(k) · Cleared

Cleared

Implanova

K210523510(k) TraditionalCleared Sep 30, 2021219-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

Dental Evolutions, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 30, 2021 after a 219-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Sep 30, 2021
Review: 219 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K210523Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

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. 2021, this device’s year, is highlighted.

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?

Read the full statement (366 words)

The Implanova® implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® system including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Short implants (6mm) are intended for delayed loading.

All 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. All 3.0mm implants must be splinted if two or more are used adjacent to each other. The 3.0mm implants (except 8mm length) are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 3.0mm implant with 8mm length is intended for delayed loading.

Implanova® All-in-One™ implants are indicated to be used when primary stability of the implant allows presence of an abutment at the time of placement. Implanova® All-in-One TM are immediately loaded by the presence of the abutment, but the occlusal forces need to be controlled and restricted while osseointergration takes place.

All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures.

The Implanova® TiTACH™ system is indicated as a removable attachment of a full arch prosthesis when used in pairs and for a partial arch prosthesis in pairs. Minimum of two attachments are indicated per arch. Indicated to secure a complete or partial denture on 2-6 implants. This prosthesis is removable by patients.

The Implanova® FRIDGE® is indicated as a fixed attachment of a full arch prosthesis when used with 6 implants. This prosthesis is fixed for patients and removable by dentists.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K210523 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210523: Implanova.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210523

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Record history

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