| K-number | K254239 |
| Device name | CyClean Cord |
| Applicant | SS GLOBAL |
| Product code | MVL |
| Device class | Class U |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
CyClean Cord is a knitted gingival retraction cord made from 100% lyocell yarn impregnated with Aluminum Chloride Hexahydrate. It is used by dental professionals to temporarily retract gingival tissue prior to obtaining dental impressions and to achieve hemostasis by removing blood, saliva, and gingival fluid from the gingival margin.
The device is an impregnated retraction cord with the same intended use, design, and technological characteristics as the predicate device. Key differences include the base material (lyocell instead of cotton), color options, and similar but slightly different thickness specifications. Both devices are non-sterile, have a 3-minute recommended contact time, 254 cm length, and a 3-year shelf life.
ISO 10993-5 (Cytotoxicity Test), ISO 10993-10 (Skin Sensitization Test), ISO 10993-23 (Skin Irritation Test), ISO 10993-11 (Acute Systemic Toxicity), and ISO 10993-1 (Biocompatibility assessment).
The subject device is substantially equivalent to the predicate device (Smartcord X, K171577) because both share the same intended use, design, and technological characteristics despite material differences. Biocompatibility testing and various performance tests confirmed the device's safety and effectiveness, supporting substantial equivalence.
View the full FDA submission: accessdata.fda.gov