The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Uno.
| Device ID | K071131 |
| 510k Number | K071131 |
| Device Name: | UNO |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-23 |
| Decision Date | 2007-07-25 |
| Summary: | summary |