The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Aquaplast Palatal Stent.
| Device ID | K973370 |
| 510k Number | K973370 |
| Device Name: | AQUAPLAST PALATAL STENT |
| Classification | Cement, Dental |
| Applicant | WFR/AQUAPLAST CORP. 30 LAWLINS PARK P.O. BOX 635 Wyckoff, NJ 07481 |
| Contact | John R Kirk |
| Correspondent | John R Kirk WFR/AQUAPLAST CORP. 30 LAWLINS PARK P.O. BOX 635 Wyckoff, NJ 07481 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1997-12-02 |