# K013647: Revolution Formula 2

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jan 16, 2002 after 72 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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.
11 later devices descend from it; 3 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) Kerr Corporation, Prodigy 3: named in the summary without a submission number

## Most influential descendants
- K120453: Filtek Bulk Fill Flowable Restorative (2012), 8 descendants of its own
- K182714: Novidia Bulk Fill Flow Composite (2019), 2 descendants of its own
- K201010: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite (2020), 1 descendant of its own
- K253513: MultiMatch Flow Chameleon AntiMicrobial Composite (2025), 0 descendants of its own
- K242713: Any-Com Bulk (2025), 0 descendants of its own

## Recalls of this device
- Oct 15, 2010 · Not classified · Z-0716-2011: Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution Formula 2 (Kerr Corporation) that some syringes and tips marked with the brand name are not man

## Indications for use
The intended use of Revolution Formula 2 is for the restoration of Class III, Class IV, and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non= stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Source page: https://510kreport.com/device/K013647
Methodology: https://510kreport.com/methodology