# K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Sep 8, 2008 after 4 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: 3 generations back to K943574 (1994). 7 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954281: Panasil Impression Material, Roydent Dental Products, Inc. (1996) Summary page 1.
- 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
- K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light (2014), 12 descendants of its own
- 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

## Indications for use
Panasil putty (putty, putty fast set, putty soft) is to be used as a preliminary material for: -Two step putty/wash impression technique. -One step putty/wash impression technique. -Two step putty/wash impression technique using a foil (plastic putty spacer) -One step putty impression technique for forming functional peripheries. Panasil binetics (putty fast, putty soft) is to be used as a preliminary material for: -Two step putty/wash impression technique. -One step putty/wash impression technique. -Two step putty/wash impression technique using a foil (plastic putty spacer) -One step putty impression technique for forming functional peripheries. Panasil tray (fast, soft) is to be used as a heavy-bodied material for: -One step impression technique (simultaneous technique) using single or dual viscosities. -Two step impression technique using dual viscosities. -Functional impressions. Panasil monophase is to be used as a medium-bodied tray or syringeable impression material for: -Taking impressions over fixed/removable restorations and implants (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. Panasil contact (two in one, plus) is to be used as a syringeable impression material for: -Two step putty/wash impression technique. -One step putty/wash impression technique. -One step impression technique using a foil (plastic putty spacer) -One step impression technique (simultaneous technique) using dual viscosities -Reline impressions. -Fabricating full or partial dentures.

Source page: https://510kreport.com/device/K082560
Methodology: https://510kreport.com/methodology