The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Life Fast Set, Life Regular Set.
Device ID | K150559 |
510k Number | K150559 |
Device Name: | Life Fast Set, Life Regular Set |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
Contact | Kerri Casino |
Correspondent | Kerri Casino SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-06 |
Decision Date | 2015-06-19 |
Summary: | summary |