# K112501: Venus Pearl PLT Refill A1

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: Dec 14, 2011 after 106 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
Longest line of descent: 1 generation back to K083610 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K073564: Venus Diamond. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K260783: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (2026), 0 descendants of its own

## Indications for use
Direct restoration of Class I - V cavities (acc. to &_V. Black) Direct composite veneers Shape corrections of teeth (i.e. diastemas, congenital defects in teeth etc.) Splinting of teeth loosened by trauma or periodontal disease Indirect restorations (inlays, veneers) Restoration of primary teeth Core build-up Repairs of porcelain, composite (in combination with an adequate repair system)

Source page: https://510kreport.com/device/K112501
Methodology: https://510kreport.com/methodology