K213260 is an FDA 510(k) clearance for the CMFlexTM. This device is classified as a Bone Grafting Material, Synthetic (Class II - Special Controls, product code LYC).
Submitted by Dimension Inx Corp. (Chicago, US). The FDA issued a Cleared decision on December 30, 2022, 456 days after receiving the submission on September 30, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3930. A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw..
| 510(k) Number | K213260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | December 30, 2022 |
| Days to Decision | 456 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LYC - Bone Grafting Material, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3930 |
| Definition | A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw. |