510(k) · Cleared

Cleared

Ace Connect Internal Connection

K041759510(k) SpecialCleared Jul 22, 200423-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

Ace Surgical Supply Co., Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Jul 22, 2004 as substantially equivalent to K954513 (Ace Surgical Supply Co., Inc., 1996) after a 23-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Jul 22, 2004
Review: 23 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954513 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK954513 Ace Srew Dentla Implant SystemAce Surgical Supply Co., Inc. · 1996
This deviceK041759 Ace Connect Internal ConnectionAce Surgical Supply Co., Inc. · 2004
Descendant · cites it directly · 0 of its ownK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008

Most influential descendants

Showing 1 of 1 · See all

K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954513	Ace Srew Dentla Implant System	Ace Surgical Supply Co., Inc.	1996	—
0 (this device)	K041759	Ace Connect Internal Connection	Ace Surgical Supply Co., Inc.	2004	—
+1	K073622	Easy Grip Dental Implant System	T.F.I. System S.R.L	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K041759, 1996–2008Source: 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? (1)

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
*	K954513	Ace Srew Dentla Implant System Summary page 1 …rew Dental Implant Classification Name: Endosseous Dental Implant, product code DZE Predicate device: ACE Screw Dental Implant System, K954513 Reason for submission: Not previously marketed in the USA Device Description and Materials: The ACE Surgical Inter…	Ace Surgical Supply Co., Inc.	1996	—

Also cleared against K954513: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073622	Easy Grip Dental Implant System	T.F.I. System S.R.L	2008	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?

Its one ancestor has no recall.
Of its descendants, K073622 (T.F.I. System S.R.L, 2008) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K954513.

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 ACE CONNECTTM Internal Connection Screw Dental Implant System is

intended to be used in totally edentulous mandibles or maxillae or as a terminal

or intermediary abutment for fixed or removable bridgework. The system can

also be used for single tooth restorations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041759 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041759: Ace Connect Internal Connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041759

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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