# K050604: Kerr VPS Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Apr 15, 2005 after 37 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M ESPE, Position Penta Quick: named in the summary without a submission number
- (no number) DMG, Status Blue Mixstar: named in the summary without a submission number

## Most influential descendants
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact (2008), 17 descendants of its own
- 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

## Recalls of this device
- Feb 21, 2012 · Class II · Z-0268-2013: The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients wit

## Indications for use
Kerr VPS Impression Material is suitable for impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions.

Source page: https://510kreport.com/device/K050604
Methodology: https://510kreport.com/methodology