The following data is part of a premarket notification filed by Caulk Co., Div. Dentsply with the FDA for Veneer System, Mostique Laminate.
Device ID | K782080 |
510k Number | K782080 |
Device Name: | VENEER SYSTEM, MOSTIQUE LAMINATE |
Classification | Agent, Tooth Bonding, Resin |
Applicant | CAULK CO., DIV. DENTSPLY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-13 |
Decision Date | 1979-01-26 |