# K091023: Metamorphosis

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: May 21, 2009 after 41 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.
11 later devices descend from it; 2 cite it directly.
0 of 12 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) Herculite Ultra: named in the summary without a submission number
- (no number) Premise Plowable: named in the summary without a submission number

## Most influential descendants
- K141081: Filtek Bulk Fill Posterior Restroative (2014), 9 descendants of its own
- K183476: 3M Filtek Universal Restorative (2019), 5 descendants of its own
- K241147: Any-Com (2024), 1 descendant of its own
- K191306: Llis, Vittra APS (2019), 1 descendant of its own
- K163207: Filtek One Bulk Fill Restorative (2016), 1 descendant of its own

## Indications for use
Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.

Source page: https://510kreport.com/device/K091023
Methodology: https://510kreport.com/methodology