510(k) · Cleared

Cleared

Straumann Extraoral Implant System

K990458510(k) TraditionalCleared Apr 16, 199963-day reviewClass I21 CFR 878.3800

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

Straumann USA · KCZ Prosthesis, Breast, External, Used With Adhesive

Cleared on Apr 16, 1999 as substantially equivalent to K971578 (Straumann USA, 1997) and 3 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided: Apr 16, 1999
Review: 63 days
Class: Class I
Product code: KCZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K945154 (1995). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945154 BA-CpasNobelpharma USA, Inc. · 1995
This deviceK990458 Straumann Extraoral Implant SystemStraumann USA · 1999
Descendant · cites it directly · 1 of its ownK161548 Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
Descendant · 2 generations on · 0 of its ownK241253 Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all

K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016 · cites it directly1descendant
K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945154	BA-Cpas	Nobelpharma USA, Inc.	1995	—
0 (this device)	K990458	Straumann Extraoral Implant System	Straumann USA	1999	—
+1	K161548	Osseointegrated Fixtures	Southern Implants (Pty), Ltd.	2016	—
+2	K241253	Medicon Epiplating System	Cmf Medicon Surgical, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2024	1	0

FIG. 1 — Lineage of K990458, 1995–2024Source: 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 KCZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K971578	Endosseous Dental Implant Summary page 1 …me:- Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040) Legcally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant (K971578) Nobel Biocare (K945154) Leibinger Epitec Implant (K961719) BUD Craniofacial Implant (K912521) Description of the Device The E…	Straumann USA	1997	—
*	K945154	BA-Cpas Summary page 1 …one Fixation Fastener (21 CFR 888.3040) Legcally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant (K971578) Nobel Biocare (K945154) Leibinger Epitec Implant (K961719) BUD Craniofacial Implant (K912521) Description of the Device The Extraoral implant is a so…	Nobelpharma USA, Inc.	1995	—
*	K961719	Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses Summary page 1 …040) Legcally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant (K971578) Nobel Biocare (K945154) Leibinger Epitec Implant (K961719) BUD Craniofacial Implant (K912521) Description of the Device The Extraoral implant is a solid, threaded, self-tapping implant…	Howmedica Leibinger, Inc.	1997	—
*	K912521	Dental Implant System 4.0MM and 5.5MM Length Summary page 1 …which Equivalence is Claimed (Predicate Devices) ITI SLA Dental Implant (K971578) Nobel Biocare (K945154) Leibinger Epitec Implant (K961719) BUD Craniofacial Implant (K912521) Description of the Device The Extraoral implant is a solid, threaded, self-tapping implant made from CP titanium, Grade 4. It…	Bud Industries, Inc.	1995	—

Also cleared against K971578: 6 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K161548	Osseointegrated Fixtures	Southern Implants (Pty), Ltd.	2016	1

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 4 ancestors has a recall.
Of its descendants, K161548 (Southern Implants (Pty), Ltd., 2016) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K971578.

How does its category compare?

All KCZ devices

KCZ Prosthesis, Breast, External, Used With Adhesive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCZ

FDA has decided no KCZ device since 2007.

Median 510(k) review, days · KCZ

Too few KCZ 510(k)s in any year since 2007 to give a median.

Recalls per year · KCZ

No recall names KCZ since 2007.

Adverse event reports per year · KCZ

1in 2024

2007high 2 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	2
2022	—	1
2023	—	0
2024	—	1
2025	—	0
2026	—	—

What is it indicated for?

The Straumann Extraoral implant is an endosseous implant intended for placement in the skull, mainly in the mastoid process, periorbital, and perinasal regions. Its purpose is to provide rigid retention for craniomaxillofacial epitheses such as eye, ear and nose epitheses.

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/K990458 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990458: Straumann Extraoral Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990458

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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