The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Kerr Vps Impression Material.
Device ID | K050604 |
510k Number | K050604 |
Device Name: | KERR VPS IMPRESSION MATERIAL |
Classification | Material, Impression |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVENUE Orange, CA 92867 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVENUE Orange, CA 92867 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-09 |
Decision Date | 2005-04-15 |
Summary: | summary |