# K053643: Stage- 1 Temporary/Healing Cap, Model 42021-42026

- Pathway: 510(k) (Special)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Jan 23, 2006 after 24 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960026 (1996). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991114: Regular Diameter Single Stage (RDS) TPS Dental Implant System, Lifecore Biomedical, Inc. (1999) Summary page 1.
- K994205: Modification of Regular Diameter Single Stage (RDS) TPS Dental Implant System, Lifecore Biomedical, Inc. (2000) Summary page 1.
- K003226: The Lifecore Stage-1 Single Stage RBM Dental Implant System, Lifecore Biomedical, Inc. (2001) Summary page 1.
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005) Summary page 1.

## Indications for use
The Stage-I® Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alone or as the base for a temporary crown. The healing cap is intended fbr temporary use only up to 30 days.

Source page: https://510kreport.com/device/K053643
Methodology: https://510kreport.com/methodology