510(k) · Cleared
ClearedSD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick Abutment, Locking, Model 45302.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · ELL Teeth, Porcelain
Cleared on May 22, 2006 as substantially equivalent to K032562 (Nobel Biocare AB, 2004) after an 83-day review. Its family tree reaches back 2 generations to 1991. 15 later devices descend from it.
- Decided
- May 22, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- ELL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910611 (1991). 4 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
- 1 generation backK032562 Proceara Copings and PonticNobel Biocare AB · 2004
- This deviceK060530 SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD…Lifecore Biomedical, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK103020 Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011
- Descendant · 3 generations on · 3 of its ownK161713 Dentium CAD/CAM AbutmentsDentium Co., Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007 · cites it directly7descendants
- K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006 · cites it directly6descendants
- K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011 · 2 generations on4descendants
- K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. · 2016 · 3 generations on3descendants
- K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910611 | Nobelpharma Ceraone Abutment System | Nobelpharma USA, Inc. | 1991 | — |
| −1 | K032562 | Proceara Copings and Pontic | Nobel Biocare AB | 2004 | — |
| 0 (this device) | K060530 | SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping… | Lifecore Biomedical, Inc. | 2006 | — |
| +1 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| +1 | K062876 | Primaconnex Ceramic Abutments | Lifecore Biomedical, Inc. | 2006 | — |
| +2 | K103020 | Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment | Atlantis Components, Inc. | 2011 | — |
| +3 | K161713 | Dentium CAD/CAM Abutments | Dentium Co., Ltd. | 2016 | — |
| +2 | K103339 | TDS Abutment for Friadent Xive | Pou YU Biotechnology Co., Ltd. | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K032562 | Proceara Copings and PonticSummary page 1…Porcelain tooth Identification of Predicate Devices * Procera® Copings and Pontic (Nobel Biocare USA Inc.) (K032562) 3. Device Description Lifecore Biomedical PrimaConnex Ceramic Copings are pre-manufactured for use as a core str… | 2004 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072241 (Lifecore Biomedical, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K032562.
How does its category compare?
All ELL devicesELL Teeth, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELL
1in 2024
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PrimaConnex Ceramic Copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations.
The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060530 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060530: SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick Abutment, Locking, Model 45302..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060530
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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