The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Adper Prompt, Adper Prompt L-pop.
Device ID | K060684 |
510k Number | K060684 |
Device Name: | ADPER PROMPT, ADPER PROMPT L-POP |
Classification | Agent, Tooth Bonding, Resin |
Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Contact | Sabine Krischer |
Correspondent | Sabine Krischer 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-15 |
Decision Date | 2006-04-24 |
Summary: | summary |