510(k) · Cleared
ClearedLifecore Conical Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 25, 1997 as substantially equivalent to K924589 (Implant Support Systems, Inc., 1994) and 2 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 25, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K944964 (1995). 4 ancestors in all, the oldest K924589 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −1 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| 0 (this device) | K965135 | Lifecore Conical Abutment | Lifecore Biomedical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K924589 | Restore Self Tapping Dental Implant SystemSummary page 1…ants (per 21 CFR 872.3165). Equivalent Device: The device is substantially equivalent to the commercially marketed products known as Lifecore Conical Abutments Systems (K924589, K954512), Branimark Miruscone Abutment System (K844984, K981728), 3i Microminiplant Systemn (Catalog # MCA 31-MCA 34), and Ster-… | 1994 |
| * | K954512 | Restore Self Tapping Dental Implant SystemSummary page 1…21 CFR 872.3165). Equivalent Device: The device is substantially equivalent to the commercially marketed products known as Lifecore Conical Abutments Systems (K924589, K954512), Branimark Miruscone Abutment System (K844984, K981728), 3i Microminiplant Systemn (Catalog # MCA 31-MCA 34), and Ster-Oss HL Ab… | 1996 |
| Kept off the family tree | K844984 | Branimark Miruscone Abutment System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ce is substantially equivalent to the commercially marketed products known as Lifecore Conical Abutments Systems (K924589, K954512), Branimark Miruscone Abutment System (K844984, K981728), 3i Microminiplant Systemn (Catalog # MCA 31-MCA 34), and Ster-Oss HL Abutment System (Catalog # 2654-2657). Device De… | |
| * | K961728 | Miruscone Abutment System Our OCR of the scanned summary read K981728, FDA’s number for Alexander Manufacturing CO. Battery Part Number H134 (Alexander Mfg. Co.), decided Jun 26, 1998, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Branimark Miruscone Abutment System”. | 1996 |
| * | — | 3i Microminiplant System Named without a submission number | |
| * | — | Ster-Oss HL Abutment System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 2 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K924589.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
Implant systems are for use in single tooth, partially edentulous, completely edentuious, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw retained) prosthetics in multiple, free standing or terminal reslorations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965135: Lifecore Conical Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965135
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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