510(k) · Cleared

Cleared

3I Ceramic Abutment System

K991947510(k) TraditionalCleared Sep 29, 1999112-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

Implant Innovations, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 29, 1999 after a 112-day review. The FDA summary names its predicate without a number. 565 later devices descend from it.

Decided: Sep 29, 1999
Review: 112 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

565 later devices descend from it, 3 citing it directly.

This deviceK991947 3I Ceramic Abutment SystemImplant Innovations, Inc. · 1999
Descendant · cites it directly · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
Descendant · 2 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
Descendant · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
Descendant · 3 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
Descendant · cites it directly · 307 of its ownK023631 Astra Tech Dental Implants-Ceramic AbutmentsAstra Tech, Inc. · 2002

Showing 5 of 565 descendants. See all descendants

Descendants cleared per year

2002high 62 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 565 · See all

K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · cites it directly476descendants
K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 2 generations on441descendants
K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 3 generations on313descendants
K023631Astra Tech Dental Implants-Ceramic AbutmentsAstra Tech, Inc. · 2002 · cites it directly307descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K991947	3I Ceramic Abutment System	Implant Innovations, Inc.	1999	—
+1	K032263	3I Patient-Specific Dental Abutment and Overdenture Bar	Implant Innovations, Inc.	2004	1
+2	K042658	Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…	Nobel Biocare Uas, Inc.	2004	—
+2	K043042	Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052	Nobel Biocare AB	2004	—
+3	K090069	Procera Implant Bridge Overdenture	Nobel Biocare AB	2009	—
+1	K023631	Astra Tech Dental Implants-Ceramic Abutments	Astra Tech, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	3	0
2005	3	0
2006	8	0
2007	5	0
2008	4	0
2009	11	0
2010	11	0
2011	16	0
2012	13	0
2013	17	0
2014	23	0
2015	27	0
2016	35	0
2017	32	0
2018	25	0
2019	22	0
2020	47	0
2021	37	0
2022	37	0
2023	54	0
2024	62	0
2025	45	0
2026	27	0

FIG. 1 — Lineage of K991947, 1999–2026Source: 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? (1)

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
*	—	Nobel Biocare “CerAdapt” abutment Named without a submission number			—

What descends from it? (565)

See all 565

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

Number	Device	Applicant	Decided	Descendants
K032263	3I Patient-Specific Dental Abutment and Overdenture Bar	Implant Innovations, Inc.	2004	476
K023631	Astra Tech Dental Implants-Ceramic Abutments	Astra Tech, Inc.	2002	307
K081786	Ziocera & Convertible System	Osstem Implant Co., Ltd.	2008	123

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?

Of its descendants, K032263 (Implant Innovations, Inc., 2004) has gone furthest, with 476 descendants of its own.

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?

Ceramic abutments are indicated for use with endosseous dental implants, to

extend the implant’s coronal aspect through the mucosal tissues and into the oral

cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for

use in the higher aesthetically required anterior regions of the oral cavity but are

not restricted for that application.

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/K991947 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991947: 3I Ceramic Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991947

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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