The following data is part of a premarket notification filed by Advantage Dental Products, Inc. with the FDA for Advantage Dental Cust Dent Impress/baseplate Trays.
| Device ID | K890712 |
| 510k Number | K890712 |
| Device Name: | ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS |
| Classification | Material, Impression Tray, Resin |
| Applicant | ADVANTAGE DENTAL PRODUCTS, INC. 3051 E. PONTIAC RD. P.O. BOX 214767 Auburn Hills, MI 48057 |
| Contact | Joseph J Pelerin |
| Correspondent | Joseph J Pelerin ADVANTAGE DENTAL PRODUCTS, INC. 3051 E. PONTIAC RD. P.O. BOX 214767 Auburn Hills, MI 48057 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-13 |
| Decision Date | 1989-04-25 |