The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Permlastic 3.
Device ID | K003650 |
510k Number | K003650 |
Device Name: | PERMLASTIC 3 |
Classification | Material, Impression |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-27 |
Decision Date | 2001-02-15 |