The following data is part of a premarket notification filed by Aci, Inc. with the FDA for Flexo Dental Resin Material.
| Device ID | K061501 |
| 510k Number | K061501 |
| Device Name: | FLEXO DENTAL RESIN MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | ACI, INC. 5830 WOODSON STE: 3 Mission, KS 66202 |
| Contact | Charles Lee |
| Correspondent | Charles Lee ACI, INC. 5830 WOODSON STE: 3 Mission, KS 66202 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-31 |
| Decision Date | 2006-07-26 |
| Summary: | summary |