# K213260: CMFlexTM

- Pathway: 510(k) (Traditional)
- Applicant: Dimension Inx Corp.
- Decided: Dec 30, 2022 after 456 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: 10 generations back to K873689 (1987). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101827: Osteoscaf, Texas Innovative Medical Devices (Dba) Skeletal (2011) Summary page 4.

## Indications for use
CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include: • Intrabony periodontal osseous defects • Furcation defects • Bony defects or bony deficiencies of the alveolar ridge • Intraoral, maxillofacial, and mandibular augmentation • Bony defects of the upper or lower jaw • Filling of tooth extraction sites • Sinus elevation grafting

Source page: https://510kreport.com/device/K213260
Methodology: https://510kreport.com/methodology