The following data is part of a premarket notification filed by Discus Dental Inc. with the FDA for Precision Vps Impression Material.
Device ID | K040053 |
510k Number | K040053 |
Device Name: | PRECISION VPS IMPRESSION MATERIAL |
Classification | Material, Impression |
Applicant | DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
Contact | Steven L Ziemba |
Correspondent | Steven L Ziemba DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-12 |
Decision Date | 2004-03-25 |
Summary: | summary |