Degubond Ultra
FDA 510(k) K953344 · Degussa AG
510(k) numberK953344
Submission
- Device name
- Degubond Ultra
- Applicant
- Degussa AG
South Plainfield, NJ, US - Received
- July 12, 1995
- Decision date
- August 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| 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 |
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| K955027 | Degubond X-LiteEJT · Traditional | 12/01/1995SE |
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Questions and answers
When was Degubond Ultra cleared by the FDA?
Degubond Ultra (K953344) received a 510(k) decision of Substantially Equivalent on August 25, 1995, 44 days after the submission was received.
What is the product code of K953344?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.