The following data is part of a premarket notification filed by Dental X Srl with the FDA for Imax 9.5 Sterilizers.
| Device ID | K052532 |
| 510k Number | K052532 |
| Device Name: | IMAX 9.5 STERILIZERS |
| Classification | Sterilizer, Steam |
| Applicant | DENTAL X SRL 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte DENTAL X SRL 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-15 |
| Decision Date | 2006-09-05 |
| Summary: | summary |