The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Poly Q (garant L, Penta M, Penta H).
| Device ID | K032001 |
| 510k Number | K032001 |
| Device Name: | POLY Q (GARANT L, PENTA M, PENTA H) |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2003-08-11 |
| Summary: | summary |