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 |