510(k) · Cleared

Cleared

Rootform Dental Implant System

K954758510(k) TraditionalCleared Aug 18, 1997672-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

Swiss Dental Center · DZE Implant, Endosseous, Root-Form

Cleared on Aug 18, 1997 as substantially equivalent to K912262 (Imtec Corp., 1991) and 2 other predicates after a 672-day review. Its family tree reaches back 1 generation to 1991.

Decided: Aug 18, 1997
Review: 672 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K912262 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK912262 HexlockImtec Corp. · 1991
This deviceK954758 Rootform Dental Implant SystemSwiss Dental Center · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912262	Hexlock	Imtec Corp.	1991	—
0 (this device)	K954758	Rootform Dental Implant System	Swiss Dental Center	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

FIG. 1 — Lineage of K954758, 1991–1997Source: 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? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K912262	Hexlock Summary page 2 ….60,]0/13/95 Pagc _ 43 _ 510(k) Premarket Notification Swiss Dental Center Rootform Dental Implant System Predicate Devices 510(k) Sponsor Device Name K912262 Imtec Corp. Mini and Universal K921966 Steri-Oss HA and TPS Coated o ; Cylmdrlcal Implants K926101 Phoenix Dental, Inc. Optl -Ma…	Imtec Corp.	1991	—
Kept off the family tree	K921966	Steri-Oss HA and TPS Coated Cylindrical Implants Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2 …= 510(k) Premarket Notification Swiss Dental Center Rootform Dental Implant System Predicate Devices 510(k) Sponsor Device Name K912262 Imtec Corp. Mini and Universal K921966 Steri-Oss HA and TPS Coated o ; Cylmdrlcal Implants K926101 Phoenix Dental, Inc. Optl -Max Dental Implant K926102 Device Descri…
*	K926101	Phoenix Opti-Max Dent Impl W/Plas-Spray Tita/Hydro Summary page 2 …Dental Implant System Predicate Devices 510(k) Sponsor Device Name K912262 Imtec Corp. Mini and Universal K921966 Steri-Oss HA and TPS Coated o ; Cylmdrlcal Implants K926101 Phoenix Dental, Inc. Optl -Max Dental Implant K926102 Device Description The Rootform Dental Implant System has two “families”…	Phoenix Dental, Inc.	1994	—
*	K926102	Phoenix Opti-Max Dent Implant W/Plasma-Spray Titan Summary page 2 …sor Device Name K912262 Imtec Corp. Mini and Universal K921966 Steri-Oss HA and TPS Coated o ; Cylmdrlcal Implants K926101 Phoenix Dental, Inc. Optl -Max Dental Implant K926102 Device Description The Rootform Dental Implant System has two “families” -- one without a hex top with 3.3 mm and 3.8 mm diamet…	Phoenix Dental, Inc.	1994	—

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?

None of the 3 ancestors has a 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.

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 Rootform Dental Implant is an endosseous dental implant intended to provide support for prosthetic attachments. The Rootform Dental Implant is surgically placed in the bone of the upper or lower jaw arches to provide attachment and support for an abutment and prosthetic devices-including artificial teeth; bridges,anddentures.

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/K954758 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954758: Rootform Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954758

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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