The following data is part of a premarket notification filed by Lang Dental Manufacturing Co., Inc. with the FDA for Orthodontic Acrylic 2.
| Device ID | K163482 |
| 510k Number | K163482 |
| Device Name: | Orthodontic Acrylic 2 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Lang Dental Manufacturing Co., Inc. 175 Messner Drive PO Box 969 Wheeling, IL 60090 |
| Contact | Dave Lang |
| Correspondent | Dave Lang Lang Dental Manufacturing Co., Inc. 175 Messner Drive PO Box 969 Wheeling, IL 60090 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-05-31 |
| Summary: | summary |