The following data is part of a premarket notification filed by Ultimate Wireforms, Inc. with the FDA for The Ultimate Rcs Arch Wire.
Device ID | K923838 |
510k Number | K923838 |
Device Name: | THE ULTIMATE RCS ARCH WIRE |
Classification | Wire, Orthodontic |
Applicant | ULTIMATE WIREFORMS, INC. 88 HARWINTON AVE. Terryville, CT 06786 |
Contact | Paul J Blanchette |
Correspondent | Paul J Blanchette ULTIMATE WIREFORMS, INC. 88 HARWINTON AVE. Terryville, CT 06786 |
Product Code | DZC |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-30 |
Decision Date | 1992-12-04 |