The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Nexus Universal, Nexus Universal Chroma.
Device ID | K151332 |
510k Number | K151332 |
Device Name: | Nexus Universal, Nexus Universal Chroma |
Classification | Cement, Dental |
Applicant | SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
Contact | Courtney Clark |
Correspondent | Courtney Clark SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-19 |
Decision Date | 2015-08-17 |
Summary: | summary |