Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit
FDA 510(k) K120695 · Dentist IN A Box Pty., Ltd.
510(k) numberK120695
Submission
- Device name
- Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit
- Applicant
- Dentist IN A Box Pty., Ltd.
Malvern, Victoria, AU - Received
- March 7, 2012
- Decision date
- June 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EMB
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|---|---|---|---|
| K161630 | Provicol QM PlusEMB · Traditional | Voco GmbH | 09/15/2016SE |
| K110759 | TempocemEMB · Abbreviated | Dmg USA, Inc. | 06/10/2011SE |
| K073539 | Provisa CemEMB · Traditional | Cavex Holland BV | 01/31/2008SE |
| K020158 | Non-Eugenol Temporary CementEMB · Traditional | J. Morita USA, Inc. | 03/07/2002SE |
| K941066 | Dental 911EMB · Traditional | L.A.F. Industries, Inc. | 05/24/1995SE |
| K861681 | Dentimedic Dental Emergency KitEMB · Traditional | Dentimedic | 09/23/1986SE |
| K862745 | Eugenol UspEMB · Traditional | E&D Dental Manufacturing Co. | 07/31/1986SE |
| K821581 | Den TempEMB · Traditional | Majestic Drug Co., Inc. | 06/14/1982SE |
| K801779 | Oxydental Zinc Oxide Eugenol(Zoe)CementEMB · Traditional | Oxy Dental Products, Inc. | 08/07/1980SE |
| K772315 | KwikapEMB · Traditional | Den-Mat Corp. | 01/03/1978SE |
Questions and answers
When was Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit cleared by the FDA?
Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit (K120695) received a 510(k) decision of Substantially Equivalent on June 12, 2012, 97 days after the submission was received.
What is the product code of K120695?
The FDA product code is EMB – Zinc Oxide Eugenol, a Class I (low risk) device regulated under 21 CFR 872.3275.