# K042583: Calc-I-Oss

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jul 19, 2005 after 300 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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 P800035 (1981). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P800035: Peri-Oss, Curasan AG (1981) Summary page 1.

## Most influential descendants
- K131385: Easy-Graft (2013), 0 descendants of its own
- K062102: Odoncer (2007), 0 descendants of its own

## Indications for use
Defects after removal of bone cysts, Periodontal defects in combination with membranes, Augmentation of alveolar crest, possibly in combination with autologous bone and membrane (Guided Bone Regeneration) Apicoectomy Extraction defects in combination with membranes Defects after surgical removal of retained teeth Sinus floor elevations Defects after removal of autologous bone

Source page: https://510kreport.com/device/K042583
Methodology: https://510kreport.com/methodology