The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Gingiknit+, Gingibraid+, Gingibraid+ Shortcut, And Unibraid+ Impregnated Aluminum Potassium Sulfate Retraction Cord.
| Device ID | K162536 |
| 510k Number | K162536 |
| Device Name: | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, And UniBraid+ Impregnated Aluminum Potassium Sulfate Retraction Cord |
| Classification | Cord, Retraction |
| Applicant | KERR CORPORATION 1717 W. COLLINS AVE Orange, CA 92867 |
| Contact | Mohammad Saad Ansari |
| Correspondent | Mohammad Saad Ansari SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVE Orange, CA 92867 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-12 |
| Decision Date | 2017-02-03 |
| Summary: | summary |