510(k) · Cleared

Cleared

6.00MM X 6.00MM Macro External Implant System

K122198510(k) TraditionalCleared Apr 5, 2013255-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

Oco Biomedical · DZE Implant, Endosseous, Root-Form

Cleared on Apr 5, 2013 as substantially equivalent to K110337 (Oco Biomedical, 2012) and 13 other predicates after a 255-day review. Its family tree reaches back 9 generations to 1990.

Decided: Apr 5, 2013
Review: 255 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 14

Its longest line of descent runs back 9 generations to K894595 (1990). 121 ancestors in all, the oldest K820013 (1982). No later device cites it as a predicate yet.

By dateBy generation

Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
5 generations between
3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
This deviceK122198 6.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013

Show all 9 generations

Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
This deviceK122198 6.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−8	K984104	Iti Dental Implant System	Straumann USA	1999	1
−7	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
−6	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
−5	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
−4	K050258	Groovy Implants	Nobel Biocare AB	2005	28
−3	K061003	SFB & CFB Implants	Nobel Biocare AB	2006	—
−2	K071370	Nobelactive Internal Connection Implant	Nobel Biocare AB	2007	4
−1	K101732	Astra Tech Implant System	Astra Tech AB	2011	—
0 (this device)	K122198	6.00MM X 6.00MM Macro External Implant System	Oco Biomedical	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1984	1	0
1988	1	0
1989	1	0
1990	2	0
1991	1	0
1993	15	0
1994	7	0
1995	10	0
1996	9	0
1997	6	0
1998	5	0
1999	7	0
2000	4	0
2001	6	0
2002	11	0
2003	4	0
2004	3	0
2005	3	0
2006	6	0
2007	2	0
2008	3	0
2009	3	0
2012	1	0

FIG. 1 — Lineage of K122198, 1990–2013Source: 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? (14)

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
*	K110337	Universal Maxillary Molar	Oco Biomedical	2012	—
*	K090174	Tsi; Eri Summary page 2 …ent in indications and design principles to the following legally marketed predicate devices: OCO.Biomedical, I Macro Implant System, KI 1033 OCO Biomedical, TSI & ERI, K090174 "0"Company, Inc., Immediate Stabilizing Implant (ISI), K033392 "0"Company, Inc., OCO Dental Implant (5.0 mm Diameter), K023336 Im…	Oco Biomedical	2009	—
*	K033392	Immediate Stabilizing Implant (Isi) Summary page 2 …ly marketed predicate devices: OCO.Biomedical, I Macro Implant System, KI 1033 OCO Biomedical, TSI & ERI, K090174 "0"Company, Inc., Immediate Stabilizing Implant (ISI), K033392 "0"Company, Inc., OCO Dental Implant (5.0 mm Diameter), K023336 Implant Direct, LLC, Spectra Dental Implant System, K061319 South…	O Co., Inc.	2003	—
*	K023336	Oco Dental Implant (5.0MM Diameter) Summary page 2 …System, KI 1033 OCO Biomedical, TSI & ERI, K090174 "0"Company, Inc., Immediate Stabilizing Implant (ISI), K033392 "0"Company, Inc., OCO Dental Implant (5.0 mm Diameter), K023336 Implant Direct, LLC, Spectra Dental Implant System, K061319 Southern Implants, Inc., Endosseous Dental Implant System, K071161 Me…	O Co., Inc.	2002	—
*	K061319	Spectra System Summary page 2 …y, Inc., Immediate Stabilizing Implant (ISI), K033392 "0"Company, Inc., OCO Dental Implant (5.0 mm Diameter), K023336 Implant Direct, LLC, Spectra Dental Implant System, K061319 Southern Implants, Inc., Endosseous Dental Implant System, K071161 Megagen Implant Company, LTD, Rescue External Implant System,…	Implant Direct, LLC	2006	4
*	K071161	Endosseous Dental Implant System Summary page 2 …nc., OCO Dental Implant (5.0 mm Diameter), K023336 Implant Direct, LLC, Spectra Dental Implant System, K061319 Southern Implants, Inc., Endosseous Dental Implant System, K071161 Megagen Implant Company, LTD, Rescue External Implant System, K08 1302 Astra Tech AB, Astra Tech Implant System, K1 01732 Bicon,…	Southern Implants, Inc.	2007	2
*	K081302	Rescue External Implant System Summary page 2 …, Spectra Dental Implant System, K061319 Southern Implants, Inc., Endosseous Dental Implant System, K071161 Megagen Implant Company, LTD, Rescue External Implant System, K08 1302 Astra Tech AB, Astra Tech Implant System, K1 01732 Bicon, Inc., 6.0 x 5.7mm Dental Implant, K01 0185 Bicon, LLC, Bicon Implants w…	Megagen Implant Co., Ltd.	2008	—
*	K101732	Astra Tech Implant System Summary page 2 …mplants, Inc., Endosseous Dental Implant System, K071161 Megagen Implant Company, LTD, Rescue External Implant System, K08 1302 Astra Tech AB, Astra Tech Implant System, K1 01732 Bicon, Inc., 6.0 x 5.7mm Dental Implant, K01 0185 Bicon, LLC, Bicon Implants with a 2.5mm Internal Connection, K092035 Bicon, LLC…	Astra Tech AB	2011	—
*	K010185	6.0 X 5.7MM Dental Implant Summary page 2 …071161 Megagen Implant Company, LTD, Rescue External Implant System, K08 1302 Astra Tech AB, Astra Tech Implant System, K1 01732 Bicon, Inc., 6.0 x 5.7mm Dental Implant, K01 0185 Bicon, LLC, Bicon Implants with a 2.5mm Internal Connection, K092035 Bicon, LLC, The Bicon 5.0 x 5.0mm and 6.0 x 5.0mm Dental Imp…	Bicon, Inc.	2002	—
*	K092035	Bicon Implants with a 2.5MM Internal Connection Summary page 2 …08 1302 Astra Tech AB, Astra Tech Implant System, K1 01732 Bicon, Inc., 6.0 x 5.7mm Dental Implant, K01 0185 Bicon, LLC, Bicon Implants with a 2.5mm Internal Connection, K092035 Bicon, LLC, The Bicon 5.0 x 5.0mm and 6.0 x 5.0mm Dental Implant, K073368 Bicon, Inc., The 5.0 x 6.0mm Dental Implant, K062044 Bi…	Bicon, LLC	2009	—
*	K073368	5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant Summary page 2 …0 x 5.7mm Dental Implant, K01 0185 Bicon, LLC, Bicon Implants with a 2.5mm Internal Connection, K092035 Bicon, LLC, The Bicon 5.0 x 5.0mm and 6.0 x 5.0mm Dental Implant, K073368 Bicon, Inc., The 5.0 x 6.0mm Dental Implant, K062044 Bicon, Inc., 4.5 x 6.0mm and 6.0 x 6.0mmn Dental Implant, K050712 Bicon, Inc…	Bicon, LLC	2008	—
*	K062044	The 5.0 X 6.0MM Dental Implant Summary page 2 …Implants with a 2.5mm Internal Connection, K092035 Bicon, LLC, The Bicon 5.0 x 5.0mm and 6.0 x 5.0mm Dental Implant, K073368 Bicon, Inc., The 5.0 x 6.0mm Dental Implant, K062044 Bicon, Inc., 4.5 x 6.0mm and 6.0 x 6.0mmn Dental Implant, K050712 Bicon, Inc., The 5.0.x 6.0mmn Dental Implant, K042637 Non-clin…	Bicon, Inc.	2006	—
*	K050712	4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant Summary page 2 …Bicon 5.0 x 5.0mm and 6.0 x 5.0mm Dental Implant, K073368 Bicon, Inc., The 5.0 x 6.0mm Dental Implant, K062044 Bicon, Inc., 4.5 x 6.0mm and 6.0 x 6.0mmn Dental Implant, K050712 Bicon, Inc., The 5.0.x 6.0mmn Dental Implant, K042637 Non-clinical testing data submitted, referenced, or relied upon to demonst…	Bicon, Inc.	2005	—
*	K042637	The 5.0 X 6.0MM Dental Implant Summary page 2 …3368 Bicon, Inc., The 5.0 x 6.0mm Dental Implant, K062044 Bicon, Inc., 4.5 x 6.0mm and 6.0 x 6.0mmn Dental Implant, K050712 Bicon, Inc., The 5.0.x 6.0mmn Dental Implant, K042637 Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering ana…	Bicon, Inc.	2004	—

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?

The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
12 of the 121 ancestors have a recall of any class.

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. 2013, this device’s year, is highlighted.

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 I Macro 6.0mmr X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulaus prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122198 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122198: 6.00MM X 6.00MM Macro External 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/K122198

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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