The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Pecd-01 And Pecd Quick-01.
| Device ID | K080514 |
| 510k Number | K080514 |
| Device Name: | PECD-01 AND PECD QUICK-01 |
| Classification | Material, Impression |
| Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Desi W Soegiarto |
| Correspondent | Desi W Soegiarto 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-03-26 |
| Summary: | summary |