The following data is part of a premarket notification filed by Biotech One, Inc. with the FDA for Korlex-gr Gingival Retraction Paste.
| Device ID | K053329 |
| 510k Number | K053329 |
| Device Name: | KORLEX-GR GINGIVAL RETRACTION PASTE |
| Classification | Cord, Retraction |
| Applicant | BIOTECH ONE, INC. 92 COSTA BRAVA Laguna Niguel, CA 92677 |
| Contact | Karen Uyesugi |
| Correspondent | Karen Uyesugi BIOTECH ONE, INC. 92 COSTA BRAVA Laguna Niguel, CA 92677 |
| 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 | 2005-12-01 |
| Decision Date | 2006-02-15 |