The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Clinpro Prophy Powder.
Device ID | K021450 |
510k Number | K021450 |
Device Name: | CLINPRO PROPHY POWDER |
Classification | Airbrush |
Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Andreas Petermann |
Correspondent | Andreas Petermann 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-06 |
Decision Date | 2002-08-01 |
Summary: | summary |