The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for Intrigue Ceramic Bracket.
Device ID | K902075 |
510k Number | K902075 |
Device Name: | INTRIGUE CERAMIC BRACKET |
Classification | Bracket, Ceramic, Orthodontic |
Applicant | LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008 |
Contact | Mike Ekinaka |
Correspondent | Mike Ekinaka LANCER ORTHODONTICS, INC. 6050 AVENIDA ENCINAS P.O. BOX 819 Carlsbad, CA 92008 |
Product Code | NJM |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-08 |
Decision Date | 1990-08-06 |