# K032921: Premise

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Nov 13, 2003 after 52 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
40 later devices descend from it; 2 cite it directly.
0 of 41 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) Point 4 Modified: named in the summary without a submission number

## Most influential descendants
- K123631: MFP-051 (2013), 39 descendants of its own
- K133824: Cerasmart (2014), 32 descendants of its own
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own
- K201668: VarseoSmile Crown plus (2020), 24 descendants of its own

## Indications for use
Premise is a dental composite restorative material intended to be used in all classes of cavites.

Source page: https://510kreport.com/device/K032921
Methodology: https://510kreport.com/methodology