The following data is part of a premarket notification filed by Teledyne Getz with the FDA for Denspro Coarse Mint Prophy Paste.
Device ID | K923674 |
510k Number | K923674 |
Device Name: | DENSPRO COARSE MINT PROPHY PASTE |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
Applicant | TELEDYNE GETZ 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 -5525 |
Contact | Riel Lebovic |
Correspondent | Riel Lebovic TELEDYNE GETZ 1550 GREENLEAF AVE. Elk Grove Village, IL 60007 -5525 |
Product Code | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-22 |
Decision Date | 1992-11-05 |