The following data is part of a premarket notification filed by 3m Company with the FDA for Spk Sealant.
| Device ID | K091632 |
| 510k Number | K091632 |
| Device Name: | SPK SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | 3M COMPANY 3M CENTER,BLDG. 275-2W-08 St. Paul, MN 55144 -1000 |
| Contact | Shari Myszka |
| Correspondent | Shari Myszka 3M COMPANY 3M CENTER,BLDG. 275-2W-08 St. Paul, MN 55144 -1000 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-04 |
| Decision Date | 2009-09-03 |
| Summary: | summary |