510(k) · Cleared

Cleared

Esthetic Zirconia Abutment

K031719510(k) SpecialCleared Jul 2, 200329-day reviewClass II21 CFR 872.3630

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

Nobel Biocare AB · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jul 2, 2003 as substantially equivalent to K913255 (Ceramic Core Corp., 1994) after a 29-day review. Its family tree reaches back 1 generation to 1994. 514 later devices descend from it.

Decided: Jul 2, 2003
Review: 29 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K913255 (1994). 514 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK913255 Ceramic (TM) AbutmentCeramic Core Corp. · 1994
This deviceK031719 Esthetic Zirconia AbutmentNobel Biocare AB · 2003
Descendant · cites it directly · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
Descendant · 2 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
Descendant · 2 generations on · 261 of its ownK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
Descendant · 3 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Descendant · 3 generations on · 200 of its ownK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010

Showing 5 of 514 descendants. See all descendants

Descendants cleared per year

2004high 56 (2024) · low 2 (2004)2026

Most influential descendants

Showing 5 of 514 · See all

K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · cites it directly441descendants
K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 2 generations on278descendants
K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Atlantis Components, Inc. · 2005 · 2 generations on261descendants
K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 3 generations on240descendants
K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc. · 2010 · 3 generations on200descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913255	Ceramic (TM) Abutment	Ceramic Core Corp.	1994	—
0 (this device)	K031719	Esthetic Zirconia Abutment	Nobel Biocare AB	2003	—
+1	K042658	Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…	Nobel Biocare Uas, Inc.	2004	—
+2	K091756	Nobelprocera TI Abutment	Nobel Biocare AB	2009	—
+2	K052070	Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis…	Atlantis Components, Inc.	2005	—
+3	K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	—
+3	K093780	Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis…	Astra Tech, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	2	0
2006	5	0
2007	5	0
2008	5	0
2009	9	0
2010	5	0
2011	11	0
2012	11	0
2013	9	0
2014	26	0
2015	29	0
2016	27	0
2017	23	0
2018	26	0
2019	26	0
2020	45	0
2021	38	0
2022	35	0
2023	48	0
2024	56	0
2025	45	0
2026	26	0

FIG. 1 — Lineage of K031719, 1994–2026Source: 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 NHA? 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 NHA device

#1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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? (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
*	K913255	Ceramic (TM) Abutment Summary page 1 …plant (21 CFR 872.3640) Trade or Proprietary or Model Name: Esthetic Zirconia Abutment Legally Marketed Device: Ceramic Abutment (K913255) Device Description: Nobel Biocare’s Esthetic Zirconia Abutment incorporates a material change to the predicate device, Ceramic…	Ceramic Core Corp.	1994	—
†	K010630	Y-TZP Powder and Procera Allzirkon	Procera Sandvik, Inc.	2001	—

Also cleared against K913255: 3 other devices →

What descends from it? (514)

See all 514

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

Number	Device	Applicant	Decided	Descendants
K042658	Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004	Nobel Biocare Uas, Inc.	2004	441
K101945	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2011	180
K072129	Nobelactive Zirconia Abutment	Nobel Biocare AB	2008	71
K041275	Procera Abutment Octagon	Nobel Biocare Uas, Inc.	2004	61
K132125	A.B. Dental Devices Dental Implants System	A.B. Dental Devices, Ltd.	2014	25
K180899	Universal Base Abutment	Nobel Biocare AB	2018	9
K051501	Zirace	Acucera, Inc.	2005	8
K133377	Nobelprocera Angulated Screw Channel Abutment Replace	Nobel Biocare AB	2014	1
K063592	Adapter PS RP-NP, 34551, Adapter PS WP-RP,34552, Abutment Screw PS RP-NP, 34553…	Nobel Biocare AB	2007	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?

Its one ancestor has no recall.
Of its descendants, K042658 (Nobel Biocare Uas, Inc., 2004) has gone furthest, with 441 descendants of its own.
3 other devices also cite its predicate K913255.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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	38	91	1	1
2008	31	90	2	8
2009	30	95	0	30
2010	19	162	0	61
2011	31	130	5	56
2012	25	171	1	5
2013	22	184	1	143
2014	27	160	0	146
2015	29	151	1	858
2016	38	202	36	314
2017	31	188	2	577
2018	31	200	1	591
2019	28	160	0	530
2020	38	153	7	458
2021	29	211	0	546
2022	33	142	0	497
2023	51	147	3	618
2024	43	158	0	635
2025	40	147	1	838
2026	23	169	3	—

What is it indicated for?

Nobel Biocare's Esthetic Zirconia Abutment is indicated for the treatment of partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031719: Esthetic Zirconia Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031719

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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