The following data is part of a premarket notification filed by Dentist In A Box Pty. Ltd with the FDA for Dentist In A Box Dental Emergency Kit Plus Tooth Trauma Care Kit.
| Device ID | K120695 |
| 510k Number | K120695 |
| Device Name: | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT |
| Classification | Zinc Oxide Eugenol |
| Applicant | DENTIST IN A BOX PTY. LTD 44 HORACE ST Malvern, Victoria, AU 3144 |
| Contact | John Banky |
| Correspondent | John Banky DENTIST IN A BOX PTY. LTD 44 HORACE ST Malvern, Victoria, AU 3144 |
| Product Code | EMB |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-07 |
| Decision Date | 2012-06-12 |
| Summary: | summary |