# K173318: Rapid HB, Rapid LB, Rapid MB

- Pathway: 510(k) (Traditional)
- Applicant: 3M Deutschland GmbH
- Decided: Oct 31, 2017 after 11 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954192 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032001: Poly Q (Garant L, Penta M, Penta H), 3M Espe AG Dental Products (2003) Summary page 5.

## Indications for use
Impressions of inlay, onlay, veneer, crown, and bridge preparations Fixation and implant impressions RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.

Source page: https://510kreport.com/device/K173318
Methodology: https://510kreport.com/methodology