# K101044: Retrieve Implant Cement

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Jun 10, 2010 after 57 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K884081 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033309: Premier Implant Cement, Model 3001450, Premier Dental Products Co. (2004) Summary page 1.
- K982400: Steri-Oss' Improv Temporary Dental Cement, Steri-Oss, Inc. (1998) Summary page 1.
- K031212: Temporary Resin Cement, Parkell, Inc. (2003)

## Indications for use
RETRIEVE Imnplant Cement is a resin-based, self-curing, dual-component dental cement. It is intended for mid- to long-term (semi-permanent) cementation of porcelain, ceramic, resin, and metal-based dental prostheses to dental implants, while allowing retrieval of the prostheses, if necessary. Retrieve can also be used as a temporary filling material.

Source page: https://510kreport.com/device/K101044
Methodology: https://510kreport.com/methodology