# K062102: Odoncer

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed, S.A.
- Decided: Apr 16, 2007 after 266 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: 5 generations back to K941780 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053374: Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM), Ossacur AG (2006) Summary page 1.
- K042583: Calc-I-Oss, Ultradent Products, Inc. (2005) Summary page 1.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 1.

## Indications for use
ODONCER Bone Grafting Material is recommended for: Augmentation or reconstructive treatment of the alveolar ridge. Filling of infrabony 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 and Guided Bone Regeneration. Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration.

Source page: https://510kreport.com/device/K062102
Methodology: https://510kreport.com/methodology