The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Modification To Prompt L-pop.
| Device ID | K001494 |
| 510k Number | K001494 |
| Device Name: | MODIFICATION TO PROMPT L-POP |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Andreas Petermann |
| Correspondent | Andreas Petermann ESPE DENTAL AG 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 | 2000-05-12 |
| Decision Date | 2000-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D82813306080 | K001494 | 000 |
| D8281330605 | K001494 | 000 |
| D8281330604 | K001494 | 000 |