# K101426: Ceros TCP Granules

- Pathway: 510(k) (Traditional)
- Applicant: Mathys, Ltd.
- Decided: Sep 15, 2010 after 117 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053022: Synthes (Usa) Chronos-Beta-TCP, Synthes (Usa) (2006) Summary page 2.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 2.
- K030682: Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3, Bioform, Inc. (2003) Summary page 2.

## Indications for use
Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros® TCP Granules may, for example, be used for: * supplementing autogenous cancellous bone * supporting and stabilizing for guided bone regeneration, "GBR" * filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy * filling bone defects resulting from traumatic or pathological origin * augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique) * filling defects after explantation of dental implants * filling small periodontal bone cavities as well as bi- and tri-furcations of teeth * the reconstruction of alveolar defects prior to providing a prosthesis * preparation of the implant bed (e.g. sinus lift) * filling bone defects around dental implant after immediate placement into extraction sockets Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.

Source page: https://510kreport.com/device/K101426
Methodology: https://510kreport.com/methodology