# K041645: DDS-ZR

- Pathway: 510(k) (Traditional)
- Applicant: Charles Scharf
- Decided: Jul 9, 2004 after 22 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K830955 (1983). 11 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K013230: Cercon Base, Degussa - Ney Dental, Inc. (2001) Summary page 1.
- K023327: Cynovad Zirkon, Cynovad (2002) Summary page 1.
- K984201: Denzir, Dentronic AB (1999) Summary page 1.

## Most influential descendants
- K072241: Primaconnex Cad/Cam Abutment System (2007), 7 descendants of its own
- K103339: TDS Abutment for Friadent Xive (2011), 3 descendants of its own
- K110778: Biodenta Customized Abutment (2011), 2 descendants of its own
- K151295: Biodenta Customized Abutment - Titanium (2015), 1 descendant of its own
- K231210: DGA Abutment (2024), 0 descendants of its own

## Indications for use
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, V (Inlays and Onlays) and restorative material intended for veneers, crowns, and bridges

Source page: https://510kreport.com/device/K041645
Methodology: https://510kreport.com/methodology