510(k) · Cleared

Cleared

Proceara Copings and Pontic

K032562510(k) TraditionalCleared Feb 6, 2004170-day reviewClass II21 CFR 872.3920

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

Cleared on Feb 6, 2004 as substantially equivalent to K910611 (Nobelpharma USA, Inc., 1991) and 2 other predicates after a 170-day review. Its family tree reaches back 1 generation to 1991. 29 later devices descend from it.

Decided: Feb 6, 2004
Review: 170 days
Class: Class II
Product code: ELL
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K910611 (1991). 3 ancestors in all. 29 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
This deviceK032562 Proceara Copings and PonticNobel Biocare AB · 2004
Descendant · cites it directly · 15 of its ownK060530 SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD…Lifecore Biomedical, Inc. · 2006
Descendant · 2 generations on · 7 of its ownK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
Descendant · 2 generations on · 6 of its ownK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
Descendant · cites it directly · 5 of its ownK041283 Procera Bridge ZirconiaNobel Biocare AB · 2004
Descendant · 3 generations on · 4 of its ownK103020 Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2004high 5 (2006) · low 0 (2005)2026

Most influential descendants

Showing 5 of 29 · See all

K060530SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…Lifecore Biomedical, Inc. · 2006 · cites it directly15descendants
K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007 · 2 generations on7descendants
K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006 · 2 generations on6descendants
K041283Procera Bridge ZirconiaNobel Biocare AB · 2004 · cites it directly5descendants
K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910611	Nobelpharma Ceraone Abutment System	Nobelpharma USA, Inc.	1991	—
0 (this device)	K032562	Proceara Copings and Pontic	Nobel Biocare AB	2004	—
+1	K060530	SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping…	Lifecore Biomedical, Inc.	2006	—
+2	K072241	Primaconnex Cad/Cam Abutment System	Lifecore Biomedical, Inc.	2007	—
+2	K062876	Primaconnex Ceramic Abutments	Lifecore Biomedical, Inc.	2006	—
+1	K041283	Procera Bridge Zirconia	Nobel Biocare AB	2004	—
+3	K103020	Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment	Atlantis Components, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	5	0
2007	3	0
2009	1	0
2010	1	0
2011	3	0
2012	1	0
2013	1	0
2014	1	0
2015	2	0
2016	4	0
2018	1	0
2022	1	0
2023	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K032562, 1991–2025Source: 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 ELL? 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 ELL device

#1 K240586 Additive Manufacturing Zirconia Customized…score 8.7 · 3 generations · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (3)

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
*	K910611	Nobelpharma Ceraone Abutment System Summary page 1 …CFR 872.3920) Trade or Proprietary or Model Name: Procera~ Copings and Pontic Legally Marketed Device(s): CeraOne Abutment System (K91 061 1) Aluminum Oxide Powder (K001418) Y-TZP Powder and…	Nobelpharma USA, Inc.	1991	—
*	K001418	Aluminum Oxide Powder, Sumicorundum AAO4S Summary page 1 …Procera~ Copings and Pontic Legally Marketed Device(s): CeraOne Abutment System (K91 061 1) Aluminum Oxide Powder (K001418) Y-TZP Powder and Procera~' AllZirkon (K0l 0630) Device Description: Nobel Biocare's Pr…	Procera Sandvik, Inc.	2000	—
*	K010630	Y-TZP Powder and Procera Allzirkon	Procera Sandvik, Inc.	2001	—

Also cleared against K910611: 4 other devices →

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K060530	SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…	Lifecore Biomedical, Inc.	2006	15
K041283	Procera Bridge Zirconia	Nobel Biocare AB	2004	5
K153534	NobelProcera HT ML Full Contour Zirconia Crown	Nobel Biocare AB	2016	3
K100512	Nobelprocera Ips E.Max Crown	Nobel Biocare AB	2010	1
K053068	Procera Bridge Laminate, Model 40-4002	Nobel Biocare AB	2006	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 3 ancestors has a recall.
Of its descendants, K060530 (Lifecore Biomedical, Inc., 2006) has gone furthest, with 15 descendants of its own.
4 other devices also cite its predicate K910611.

How does its category compare?

All ELL devices

ELL Teeth, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELL

1in 2024

2007high 2 (2016) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELL

Too few ELL 510(k)s in any year since 2007 to give a median.

Recalls per year · ELL

No recall names ELL since 2007.

Adverse event reports per year · ELL

1in 2020

2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code ELL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	1
2015	0	—	0
2016	2	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	1
2021	0	—	0
2022	1	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Nobel Biocare's Procera Copings and Ponttic are indicated for use as core structures of an artificial prosthesis, i.e. a three-unit bridge, for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.

The Pontic is indicated as the core structure of the center unit and the Copings are indicated as the core structures of the two side crowns, thereby forming the three-unit bridge.

The Copings are also indicated for use as single crowns that will be cemented to a natural or artificial tooth abutment in the treatment of partially edentulous patients in order to restore chewing function.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032562 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032562: Proceara Copings and Pontic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032562

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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