The following data is part of a premarket notification filed by Progressive Technology, Inc. with the FDA for Aura Ceramic Dental Appliance.
Device ID | K902390 |
510k Number | K902390 |
Device Name: | AURA CERAMIC DENTAL APPLIANCE |
Classification | Bracket, Metal, Orthodontic |
Applicant | PROGRESSIVE TECHNOLOGY, INC. 12122 DRY CREEK RD., SUITE 101 Auburn, CA 95602 |
Contact | Shannon Rogers |
Correspondent | Shannon Rogers PROGRESSIVE TECHNOLOGY, INC. 12122 DRY CREEK RD., SUITE 101 Auburn, CA 95602 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-30 |
Decision Date | 1990-08-13 |