The following data is part of a premarket notification filed by Valplast Intl. Corp. with the FDA for Valplast Yamahachi Teeth.
| Device ID | K060507 |
| 510k Number | K060507 |
| Device Name: | VALPLAST YAMAHACHI TEETH |
| Classification | Denture, Plastic, Teeth |
| Applicant | VALPLAST INTL. CORP. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane VALPLAST INTL. CORP. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-04-07 |
| Summary: | summary |