Cleared Traditional

CMFlexTM

K213260 · Dimension Inx Corp. · Dental

Dec 2022

Decision

456d

Days

Class 2

Risk

About This 510(k) Submission

K213260 is an FDA 510(k) clearance for the CMFlexTM, 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 review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K213260 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.