The following data is part of a premarket notification filed by Dentall Corp. with the FDA for Spirit, Model M, U; Docportmacro, Model M, U, L.
| Device ID | K061658 |
| 510k Number | K061658 |
| Device Name: | SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTALL CORP. 3 FARADAY #B Irvine, CA 92618 |
| Contact | Edwin First |
| Correspondent | Edwin First DENTALL CORP. 3 FARADAY #B Irvine, CA 92618 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2006-09-18 |
| Summary: | summary |