# K053374: Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)

- Pathway: 510(k) (Abbreviated)
- Applicant: Ossacur AG
- Decided: Feb 21, 2006 after 78 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: 4 generations back to K941780 (1995). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K042583: Calc-I-Oss, Ultradent Products, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K092194: Polybone Dental (2010), 0 descendants of its own
- K062102: Odoncer (2007), 0 descendants of its own

## Indications for use
OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for: Augmentation or reconstructive treatment of the alveolar ridge. Filling of periodontal defects. Filling of defects after root resection, apicoectomy, and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for GBR.

Source page: https://510kreport.com/device/K053374
Methodology: https://510kreport.com/methodology