The following data is part of a premarket notification filed by Eurodent, Inc. with the FDA for Isolight.
Device ID | K894059 |
510k Number | K894059 |
Device Name: | ISOLIGHT |
Classification | Light, Operating, Dental |
Applicant | EURODENT, INC. 1381, RUE AMPERE BOUCHERVILLE, QUEBEC Canada J4b 5z5, CA |
Contact | Aldo Marucchi-foino |
Correspondent | Aldo Marucchi-foino EURODENT, INC. 1381, RUE AMPERE BOUCHERVILLE, QUEBEC Canada J4b 5z5, CA |
Product Code | EAZ |
CFR Regulation Number | 872.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-07 |
Decision Date | 1989-09-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ISOLIGHT 87196386 5402658 Live/Registered |
IsoPlexis Corporation 2016-10-07 |
ISOLIGHT 79003804 3011613 Dead/Cancelled |
Hagenberger oHG 2004-01-29 |
ISOLIGHT 75549878 not registered Dead/Abandoned |
Lafarge Corporation 1998-09-08 |