510(k) · Cleared

Cleared

Branemark System Zygomaticus Fixture System

K970499510(k) TraditionalCleared Oct 16, 1997248-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

Nobel Biocare Uas, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Oct 16, 1997 as substantially equivalent to K925762 (Nobelpharma USA, Inc., 1993) and 7 other predicates after a 248-day review. Its family tree reaches back 1 generation to 1993. 50 later devices descend from it.

Decided: Oct 16, 1997
Review: 248 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 8

Its longest line of descent runs back 1 generation to K925771 (1993). 8 ancestors in all. 50 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
This deviceK970499 Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997
Descendant · cites it directly · 32 of its ownK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
Descendant · cites it directly · 31 of its ownK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
Descendant · 2 generations on · 24 of its ownK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
Descendant · 2 generations on · 21 of its ownK070841 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007
Descendant · cites it directly · 19 of its ownK070182 Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2004high 6 (2018) · low 0 (2009)2026

Most influential descendants

Showing 5 of 50 · See all

K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004 · cites it directly32descendants
K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005 · cites it directly31descendants
K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006 · 2 generations on24descendants
K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · 2 generations on21descendants
K070182Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007 · cites it directly19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925771	Branemark System Titanium Cover Screws	Nobelpharma USA, Inc.	1993	—
0 (this device)	K970499	Branemark System Zygomaticus Fixture System	Nobel Biocare Uas, Inc.	1997	—
+1	K033171	Nsi Hexed and Non-Hexed Implant System and Immediate Loading	Northern Implants, LLC	2004	—
+1	K052490	Endosseous Dental Implant System	Northern Implants, LLC	2005	—
+2	K061169	Endosseous Dental Implant	Northern Implants, LLC	2006	—
+2	K070841	Endosseous Dental Implant System	Southern Implants, Inc.	2007	—
+1	K070182	Zygoma Implant (Immediate Function)	Nobel Biocare AB	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	4	0
1994	1	0
1995	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	4	0
2008	2	0
2010	1	0
2012	1	0
2013	2	0
2015	1	0
2016	3	0
2017	3	0
2018	6	0
2019	3	0
2020	4	0
2021	3	0
2022	2	0
2023	5	0
2024	3	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K970499, 1993–2026Source: 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? (8)

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
*	K925762	Branemark System Self-Tapping Fixture Summary page 1 …xture System. C. The Predicate Product The predicate products used in chis Premarket Notification are other components marketed by Nobel Biocare including the Fixwres, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The…	Nobelpharma USA, Inc.	1993	1
*	K925770	Branemark System Drills and Countersinks Summary page 1 …The Predicate Product The predicate products used in chis Premarket Notification are other components marketed by Nobel Biocare including the Fixwres, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate product…	Nobelpharma USA, Inc.	1993	—
*	K925775	Branemark System Machine Inst. Acc. to Drilling EQ Summary page 1 …The predicate products used in chis Premarket Notification are other components marketed by Nobel Biocare including the Fixwres, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill G…	Nobelpharma USA, Inc.	1993	—
*	K925771	Branemark System Titanium Cover Screws Summary page 1 …used in chis Premarket Notification are other components marketed by Nobel Biocare including the Fixwres, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is…	Nobelpharma USA, Inc.	1993	—
*	K925774	Branemark System Hand Instrument Summary page 1 …tion are other components marketed by Nobel Biocare including the Fixwres, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is manufactured by Ace Surgical Su…	Nobelpharma USA, Inc.	1993	—
*	K925483	Branemark Syst. Hand Inst. Dia 297 & Sdia 276 Summary page 1 …other components marketed by Nobel Biocare including the Fixwres, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is manufactured by Ace Surgical Supply Co.…	Nobelpharma USA, Inc.	1994	—
*	K953774	Branemark Restorative Instrument & Component Tray Summary page 1 …keted by Nobel Biocare including the Fixwres, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is manufactured by Ace Surgical Supply Co. D. Description of t…	Nobelpharma USA, Inc.	1995	—
*	K951510	Ace Bone Screw Tacking Kit Summary page 1 …s, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is manufactured by Ace Surgical Supply Co. D. Description of the Device The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus F…	Ace Surgical Supply Co., Inc.	1995	—

Also cleared against K925762: 1 other device →

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K033171	Nsi Hexed and Non-Hexed Implant System and Immediate Loading	Northern Implants, LLC	2004	32
K052490	Endosseous Dental Implant System	Northern Implants, LLC	2005	31
K070182	Zygoma Implant (Immediate Function)	Nobel Biocare AB	2007	19
K082651	Endosseous Dental Implant System	Southern Implants, Inc.	2008	14
K093562	Endosseous Dental Implant	Southern Implants, Inc.	2010	10

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?

1 of the 8 ancestors has a recall of any class.
Of its descendants, K033171 (Northern Implants, LLC, 2004) has gone furthest, with 32 descendants of its own.
1 other device also cites its predicate K925762.

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 Nobel Biocare Brinemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanjum intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient’s chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

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/K970499 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970499: Branemark System Zygomaticus Fixture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970499

Report an extraction error

Are you the manufacturer?

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