510(k) · Cleared

Cleared

Bicortical Screw

K983120510(k) TraditionalCleared Jul 29, 1999328-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

Oraltronics Marketing-Und Vertriebs GmbH · DZE Implant, Endosseous, Root-Form

Cleared on Jul 29, 1999 as substantially equivalent to K972351 (Sendax Mdic Management, Inc., 1997) and 5 other predicates after a 328-day review. Its family tree reaches back 1 generation to 1982. 94 later devices descend from it.

Decided: Jul 29, 1999
Review: 328 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K820013 (1982). 6 ancestors in all. 94 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK820013 Titanium Implant DevicesBofors Nobelpharma, Inc. · 1982
This deviceK983120 Bicortical ScrewOraltronics Marketing-Und Vertriebs GmbH · 1999
Descendant · cites it directly · 86 of its ownK053242 Pitt-Easy Dental Implant SystemInnova Life Sciences Corp. · 2006
Descendant · 2 generations on · 84 of its ownK083297 Pitt-Easy Dental Implant SystemSybron Implant Solutions GmbH · 2009
Descendant · 3 generations on · 83 of its ownK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
Descendant · 4 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
Descendant · 5 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012

Showing 5 of 94 descendants. See all descendants

Descendants cleared per year

2003high 9 (2022) · low 0 (2004)2026

Most influential descendants

Showing 5 of 94 · See all

K053242Pitt-Easy Dental Implant SystemInnova Life Sciences Corp. · 2006 · cites it directly86descendants
K083297Pitt-Easy Dental Implant SystemSybron Implant Solutions GmbH · 2009 · 2 generations on84descendants
K102804Spi Titanium Base for Cad/CamThommen Medical AG · 2011 · 3 generations on83descendants
K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 4 generations on45descendants
K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 5 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K820013	Titanium Implant Devices	Bofors Nobelpharma, Inc.	1982	—
0 (this device)	K983120	Bicortical Screw	Oraltronics Marketing-Und Vertriebs GmbH	1999	—
+1	K053242	Pitt-Easy Dental Implant System	Innova Life Sciences Corp.	2006	—
+2	K083297	Pitt-Easy Dental Implant System	Sybron Implant Solutions GmbH	2009	—
+3	K102804	Spi Titanium Base for Cad/Cam	Thommen Medical AG	2011	—
+4	K103691	Biohorizons Abutments for Zimmer	BioHorizons Implant Systems, Inc.	2011	1
+5	K112440	AB Dental Devices Implants and Accessories	A.B. Dental Devices, Ltd.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1993	2	0
1994	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2008	1	0
2009	2	0
2011	3	0
2012	3	0
2013	3	0
2014	4	0
2015	2	0
2016	8	0
2017	4	0
2018	4	0
2019	5	0
2020	8	0
2021	6	0
2022	9	0
2023	8	0
2024	8	0
2025	9	0
2026	5	0

FIG. 1 — Lineage of K983120, 1982–2026Source: 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

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What was it cleared against? (7)

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
*	K972351	Sendax Mdi (Mini Dental Implant) Summary page 6 …principles to the following predicate devices: Park Dental Research Corp. Pin Implant, a preamendments device that is marketed in the United States, and the Sendax MDI™ (K972351) and the Branemark Fixture (K820013, K841551, K925764, K925765, K934825), implant systems that have been cleared for marketing in…	Sendax Mdic Management, Inc.	1997	—
*	K820013	Titanium Implant Devices Summary page 6 …e devices: Park Dental Research Corp. Pin Implant, a preamendments device that is marketed in the United States, and the Sendax MDI™ (K972351) and the Branemark Fixture (K820013, K841551, K925764, K925765, K934825), implant systems that have been cleared for marketing in the United States. Intended Uses…	Bofors Nobelpharma, Inc.	1982	—
*	K841551	Osseointegrated Fixtures-Tissue Integr Summary page 6 …: Park Dental Research Corp. Pin Implant, a preamendments device that is marketed in the United States, and the Sendax MDI™ (K972351) and the Branemark Fixture (K820013, K841551, K925764, K925765, K934825), implant systems that have been cleared for marketing in the United States. Intended Uses The indic…	Bofors Nobelpharma, Inc.	1984	—
*	K925764	Branemark System 4.00 MM Fixture Summary page 6 …ntal Research Corp. Pin Implant, a preamendments device that is marketed in the United States, and the Sendax MDI™ (K972351) and the Branemark Fixture (K820013, K841551, K925764, K925765, K934825), implant systems that have been cleared for marketing in the United States. Intended Uses The indications fo…	Nobelpharma USA, Inc.	1993	—
*	K925765	Branemark System Standard 3.75MM Fixture Summary page 6 …arch Corp. Pin Implant, a preamendments device that is marketed in the United States, and the Sendax MDI™ (K972351) and the Branemark Fixture (K820013, K841551, K925764, K925765, K934825), implant systems that have been cleared for marketing in the United States. Intended Uses The indications for use for…	Nobelpharma USA, Inc.	1993	—
*	K934825	Branemark System Summary page 6 …. Pin Implant, a preamendments device that is marketed in the United States, and the Sendax MDI™ (K972351) and the Branemark Fixture (K820013, K841551, K925764, K925765, K934825), implant systems that have been cleared for marketing in the United States. Intended Uses The indications for use for the Bico…	Nobelpharma USA, Inc.	1994	—
*	—	Park Dental Research Corp. Pin Implant Named without a submission number			—

Also cleared against K972351: 7 other devices →

What descends from it? (94)

See all 94

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

Number	Device	Applicant	Decided	Descendants
K053242	Pitt-Easy Dental Implant System	Innova Life Sciences Corp.	2006	86
K033392	Immediate Stabilizing Implant (Isi)	O Co., Inc.	2003	5
K072917	JJG Evolution Orthodontic Implant System	Odontit S.A.	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?

None of the 6 ancestors has a recall.
Of its descendants, K053242 (Innova Life Sciences Corp., 2006) has gone furthest, with 86 descendants of its own.
7 other devices also cite its predicate K972351.

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 Bicortical Screw is intended for surgical placement in edentulous anterior regions of the maxillary and/or mandibular arch to support crowns, bridges, or overdentures. In many cases the Bicortical Screw is inserted immediately after extraction.

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/K983120 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983120: Bicortical Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983120

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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