# K965135: Lifecore Conical Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Feb 25, 1997 after 64 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944964 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924589: Restore Self Tapping Dental Implant System, Implant Support Systems, Inc. (1994) Summary page 1.
- K954512: Restore Self Tapping Dental Implant System, Lifecore Biomedical, Inc. (1996) Summary page 1.
- K961728: Miruscone Abutment System, Nobelpharma USA, Inc. (1996). 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”.
- (no number) 3i Microminiplant System: named in the summary without a submission number
- (no number) Ster-Oss HL Abutment System: named in the summary without a submission number

## Cited in the summary but 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K965135
Methodology: https://510kreport.com/methodology