Tytin R
FDA 510(k) K951663 · Kerr Corporation (Danbury)
510(k) numberK951663
Submission
- Device name
- Tytin R
- Applicant
- Kerr Corporation (Danbury)
Glendora, CA, US - Received
- April 10, 1995
- Decision date
- June 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053114 | SilverfilEJJ · Traditional | Dunia Perwira Manufacturing Sdn. Bhd. | 11/15/2005SE |
| K051010 | Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special | Septodont | 05/02/2005SE |
| K033434 | BestaloyEJJ · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032152 | Benco AdmixEJJ · Traditional | Southern Dental Industries, Inc. | 08/06/2003SE |
| K031658 | Benco SphericalEJJ · Traditional | Southern Dental Industries, Inc. | 07/29/2003SE |
| K020452 | High Silver ConventionalEJJ · Traditional | Ab Ardent | 05/07/2002SE |
| K011801 | Futura Topcap Non GAMMA-2EJJ · Traditional | Ab Ardent | 08/16/2001SE |
| K002811 | Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
| K002810 | Ana 3000 SM Non Gamma 2 Modified Spherical Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
| K002808 | Ana 2000 Non Gamma 2 Extra High Copper Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
More from Nordiska Dental AB
| 510(k) | Device | Decision |
|---|---|---|
| K051545 | L.E. Demetron IIEBZ · Traditional | 07/18/2005SE |
| K020091 | Optilux 501EBZ · Traditional | 03/21/2002SE |
| K951511 | Tytin AdmixEJJ · Traditional | 05/02/1995SE |
| K942480 | M4 Contra-Angle HandpieceEGS · Traditional | 01/27/1995SE |
| K940513 | OptibondKLE · Traditional | 04/15/1994SE |
| K935535 | TytinEJJ · Traditional | 03/11/1994SE |
| K934690 | Kerr Optibond, ModificationKLE · Traditional | 12/30/1993SE |
| K923546 | OptibondKLE · Traditional | 09/29/1992SE |
| K915847 | Automix Dental AmalgamatorEFD · Traditional | 03/02/1992SE |
| K904756 | MatricsESD · Traditional | 03/15/1991SE |
Questions and answers
When was Tytin R cleared by the FDA?
Tytin R (K951663) received a 510(k) decision of Substantially Equivalent on June 6, 1995, 57 days after the submission was received.
What is the product code of K951663?
The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.