The following data is part of a premarket notification filed by Health-dent Intl., Inc. with the FDA for Dent-temp Acrylic.
| Device ID | K972198 |
| 510k Number | K972198 |
| Device Name: | DENT-TEMP ACRYLIC |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | HEALTH-DENT INTL., INC. 122-A KIRKLAND CIRCLE Oswego, IL 60543 |
| Contact | Jashan Seth |
| Correspondent | Jashan Seth HEALTH-DENT INTL., INC. 122-A KIRKLAND CIRCLE Oswego, IL 60543 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-11 |
| Decision Date | 1997-12-17 |