510(k) · Cleared
ClearedPrimaconnex Cad/Cam Abutment System
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 9, 2007 as substantially equivalent to K041645 (Charles Scharf, 2004) and 4 other predicates after an 88-day review. Its family tree reaches back 10 generations to 1996. 7 later devices descend from it.
- Decided
- Nov 9, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K960026 (1996). 73 ancestors in all, the oldest K830955 (1983). 7 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 deviceK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK110778 Biodenta Customized AbutmentBiodenta Swiss AG · 2011
- Descendant · 2 generations on · 1 of its ownK151295 Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015
- Descendant · 3 generations on · 0 of its ownK231210 DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK150296 Biodenta Customized Abutment-HybridBiodenta Swiss AG · 2015
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 deviceK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011 · cites it directly3descendants
- K110778Biodenta Customized AbutmentBiodenta Swiss AG · 2011 · cites it directly2descendants
- K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015 · 2 generations on1descendant
- K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024 · 3 generations on0descendants
- K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG · 2015 · 2 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) | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| +1 | K103339 | TDS Abutment for Friadent Xive | Pou YU Biotechnology Co., Ltd. | 2011 | — |
| +1 | K110778 | Biodenta Customized Abutment | Biodenta Swiss AG | 2011 | — |
| +2 | K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | 2015 | — |
| +3 | K231210 | DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. | 2024 | — |
| +2 | K150296 | Biodenta Customized Abutment-Hybrid | Biodenta Swiss AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 9 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K041645 | DDS-ZRSummary page 1…NHA, ELL Identification of Predicate Devices * DDS-ZR Zirconia (DDS Services) (K041645) * PrimaConnex Implant System (Li… | 2004 |
| * | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection… | 2005 |
| * | K053373 | Atlantis Abutment for Zimmer InterfaceSummary page 1…ts'Abutment for Zimmer Internal Connection (Atlantis Components, Inc.) (K053373) * PrimaConnex Ceramic Copings (… | 2006 |
| * | K060530 | SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…Summary page 1…c.) (K053373) * PrimaConnex Ceramic Copings (Lifecore Biomedical, Inc.) (K060530) * Atlantis Components'Abutment for… | 2006 |
| * | K070833 | Atlantis Abutment for Astra ImplantSummary page 1…tis Components'Abutment for Astra Implant (Atlantis Components, Inc.) (K070833) Confidential 23 Lifecore Biomed… | 2007 |
What descends from it? (7)
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 11 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 6 of the 73 ancestors have a recall of any class.
- Of its descendants, K103339 (Pou YU Biotechnology Co., Ltd., 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The Lifecore PrimaConnex® CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The 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 on Lifecore PrimaConnex CAD/CAM Abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072241: Primaconnex Cad/Cam Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072241
Report an extraction error
Are you the manufacturer?
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