# K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Germany GmbH
- Decided: Mar 7, 2014 after 112 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 K943574 (1994). 8 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact, Kettenbach GmbH & Co. KG (2008) Summary page 1.
- K954281: Panasil Impression Material, Roydent Dental Products, Inc. (1996). Our reading of the summary gave K954282, FDA’s number for Ultracuff Blood Pressure Cuff and Inflation Bag (Statcorp, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Panasil Impression Materials”.
- K021413: Aquasil Ultra Rigid Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 1.
- K021410: Aquasil Ultra XLV Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 1.
- K050604: Kerr VPS Impression Material, Sybron Dental Specialties, Inc. (2005) Summary page 1.

## Most influential descendants
- K151262: Hyflex Heavy, Hyflex Mono, Hyflex Light (2015), 11 descendants of its own
- K170736: HySil Impression Materials (2017), 10 descendants of its own
- K214086: Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty (2022), 2 descendants of its own
- K192941: HySil Super Fast Impression Materials (2020), 2 descendants of its own
- K181236: HySil Impression Materials (2018), 1 descendant of its own

## Indications for use
Suflex Putty is to be used as panasil putty material for: - Two step putty impression technique - One step putty impression technique - Two step putty impression technique using a foil(plastic putty spacer) - One step putty impression technique for forming functional peripheries. Suflex Heavy is to be used a s panasil tray material for; - One step impression technique using single or dual viscosities. - Two step impression technique using dual viscosities - Functional impressions. Suflex Mono is to be used as panasil monophase material for, - Taking impression over fixed/removable restorations and implants (transerring impression posts and bridge components) - Functional impressions. - Fabricating crown and bridgework or inlays. - Fabricating ill or partial dentures. - Reline impressions. - Use in the simultaneous mixing technique as well as the putty - Transferring root posts when fabricating posts and cores indirectly. Suflex Light is to be used as panasil contact material for - Two step putty impression technique. - One step putty impression technique. - One step impression technique using a foil(plastic putty spacer) - One step impression technique (simultaneous technique) using dual viscosities. - Reline impressions. - Fabricating fill or partial denture.

Source page: https://510kreport.com/device/K133527
Methodology: https://510kreport.com/methodology