The following data is part of a premarket notification filed by Svenska Dental Instruments Ab with the FDA for Clean 'n' Oil.
| Device ID | K022264 |
| 510k Number | K022264 |
| Device Name: | CLEAN 'N' OIL |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | SVENSKA DENTAL INSTRUMENTS AB PO BOX 723 FINVIDS VAG 8 Upplands Vaesby, SE 194 27 |
| Contact | Emma Bergquist |
| Correspondent | Emma Bergquist SVENSKA DENTAL INSTRUMENTS AB PO BOX 723 FINVIDS VAG 8 Upplands Vaesby, SE 194 27 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-12 |
| Decision Date | 2002-10-02 |