510(k) · Cleared
ClearedPrimaconnex Ceramic Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 1, 2006 as substantially equivalent to K051614 (Lifecore Biomedical, Inc., 2005) and 2 other predicates after a 36-day review. Its family tree reaches back 10 generations to 1996. 6 later devices descend from it.
- Decided
- Nov 1, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K960026 (1996). 44 ancestors in all, the oldest K894595 (1990). 6 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations between
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 1 generation backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- This deviceK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK103020 Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK161713 Dentium CAD/CAM AbutmentsDentium Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK221972 Warantec Custom AbutmentWarantec Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK171622 Dentium Ti-BaseDentium Co., Ltd. · 2018
Show all 10 generations
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 1 generation backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- This deviceK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011 · cites it directly4descendants
- K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. · 2016 · 2 generations on3descendants
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 3 generations on0descendants
- K221972Warantec Custom AbutmentWarantec Co., Ltd. · 2023 · 3 generations on0descendants
- K171622Dentium Ti-BaseDentium Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −9 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −3 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −2 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −1 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| 0 (this device) | K062876 | Primaconnex Ceramic Abutments | Lifecore Biomedical, Inc. | 2006 | — |
| +1 | K103020 | Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment | Atlantis Components, Inc. | 2011 | — |
| +2 | K161713 | Dentium CAD/CAM Abutments | Dentium Co., Ltd. | 2016 | — |
| +3 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
| +3 | K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | 2023 | — |
| +3 | K171622 | Dentium Ti-Base | Dentium Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 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
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 | Decided |
|---|---|---|---|
| * | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Summary page 2…ations. 5. Substantial Equivalence Comparison Summary of how the PrimaConnex Ceramic Abutment is substantially equivalent to the PrimaConnex Esthetic Contour Abutment (K051614): * Have the same intended use, * Incorporate the identical design, * Have the same shelf life, and * Are packaged an… | 2005 |
| * | K060530 | SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…Summary page 1…(KO51614) PrimaConnex Ceramic Copings, Lifecore Biomedical (K060530) Astra Tech Implants - Dental System Ceram… | 2006 |
| * | K023631 | Astra Tech Dental Implants-Ceramic AbutmentsSummary page 1…Astra Tech Implants - Dental System Ceramic Abutment, Astra Tech, Inc. (K023631) 3. Device Description PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Conne… | 2002 |
What descends from it? (6)
2 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 10 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 5 of the 44 ancestors have a recall of any class.
- Of its descendants, K103020 (Atlantis Components, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K051614.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 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?
PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Inplant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062876: Primaconnex Ceramic Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062876
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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