The following data is part of a premarket notification filed by Denfotex Light Systems Ltd with the FDA for Savedent Blue.
| Device ID | K042196 |
| 510k Number | K042196 |
| Device Name: | SAVEDENT BLUE |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENFOTEX LIGHT SYSTEMS LTD UNIT 15, BELLEKNOWES IND.EST Inverkeithing Fife, Scotland, GB Ky11 1h7 |
| Contact | John Colles |
| Correspondent | William J Sammons UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-13 |
| Decision Date | 2004-11-01 |
| Summary: | summary |