DW250 #91
FDA 510(k) K944557 · Rms Div.
510(k) numberK944557
Submission
- Device name
- DW250 #91
- Applicant
- Rms Div.
Amherst, NY, US - Received
- September 16, 1994
- Decision date
- November 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052463 | Prometal HN86EJT · Traditional | Prometal Technologies | 10/14/2005SE |
| K041378 | Bio 60EJT · Traditional | Kodent, Inc. | 08/02/2004SE |
| K040672 | Porta ReflexEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/27/2004SE |
| K040524 | Porta Solder 1090 WEJT · Traditional | Wieland Dental + Technik GmbH & Co. KG | 05/20/2004SE |
| K040043 | NDX-40 AlloyEJT · Traditional | Heraeus Kulzer, Inc. | 03/03/2004SE |
| K034049 | Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional | Heraeus Kulzer,GmbH | 03/01/2004SE |
| K033279 | Gold Dental Casting AlloysEJT · Traditional | Bego U.S.A. | 01/15/2004SE |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/13/2003SE |
| K033435 | E-Sarang 86, DM78, DM55EJT · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032320 | Appollo 3 AlloyEJT · Traditional | Dentsply International | 10/01/2003SE |
More from Dentsply International
| 510(k) | Device | Decision |
|---|---|---|
| K963367 | RMS K-WireHTY · Traditional | 10/30/1996SE |
| K954438 | Sunmed's Greenline Fiber Optic LaryngoscopeCCW · Traditional | 12/29/1995SE |
| K944848 | The Vivacare T.P.S. ProbeEIX · Traditional | 12/14/1994SE |
| K941625 | DW234 #29EJS · Traditional | 06/22/1994SE |
| K902403 | Elite R/F Spot Film DriveIXL · Traditional | 08/01/1990SE |
| K902146 | SFD-035 Spot Film DeviceIXL · Traditional | 05/31/1990SE |
| K896665 | EXT-600 Table, Radiographic, ElevatingIZZ · Traditional | 01/22/1990SE |
| K896119 | RMS 90/15 Radiographic/Fluoroscopic Tilting TableIXR · Traditional | 11/27/1989SE |
| K896324 | Elite 1500 Radiographic Tilting TableIXR · Traditional | 11/21/1989SE |
Questions and answers
When was DW250 #91 cleared by the FDA?
DW250 #91 (K944557) received a 510(k) decision of Substantially Equivalent on November 3, 1994, 48 days after the submission was received.
What is the product code of K944557?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.