The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Nu-glaze.
Device ID | K781935 |
510k Number | K781935 |
Device Name: | NU-GLAZE |
Classification | Teeth, Porcelain |
Applicant | DERINGER-NEY INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELL |
CFR Regulation Number | 872.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-20 |
Decision Date | 1978-12-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06970553800041 | K781935 | 000 |
06970553800027 | K781935 | 000 |
06970553800010 | K781935 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NU-GLAZE 71605316 0558146 Dead/Expired |
MACKLANBURG DUNCAN COMPANY 1950-10-23 |