# K213890: IMICRYL Impression Materials

- Pathway: 510(k) (Traditional)
- Applicant: Imicryl Dis Malzemeleri San. VE Tic. A.S.
- Decided: Feb 11, 2022 after 60 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: 7 generations back to K943574 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170736: HySil Impression Materials, Osstem Implant Co., Ltd. (2017) Summary page 6.

## Indications for use
PUTTY SOFT is to be used as preliminary materials for: -Two-step Putty-wash impression technique -One-step Putty-wash impression technique HEAVY BODY materials for: -One-step impression technique (simultaneous technique) using single or dual viscosities -Two-step impression technique using dual viscosities -Functional impression MEDIUM/MONOPHASE/REGULAR BODY tray or syringeable impression material for: -Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components) -Functional impressions -Fabricating crown and bridgework or inlays -Fabricating full or partial dentures -Reline impressions -Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques -Transferring root posts when fabricating posts and cores indirectly LIGHT BODY is to be used as syringeable impression materials for: -Two-step putty-wash impression technique -One-step putty-wash impression technique -Two-step impression technique using dual viscosities -Reline impressions -Fabricating full or partial dentures EXTRA LIGHT BODY is to be used as syringeable impression materials for: -Two-step putty-wash impression technique -One-step putty-wash impression technique -Two-step impression technique using dual viscosities -Reline impressions -Fabricating full or partial dentures BITE REGISTRATION is used for impression as below. -Taking occlusal surfaces -Confirming occlusal surfaces -Recording after putting the articulator

Source page: https://510kreport.com/device/K213890
Methodology: https://510kreport.com/methodology