DW242-07 Non-Precious Alloy F/ Porcelain Fus. Met.
FDA 510(k) K920561 · Ivoclar North America, Inc.
510(k) numberK920561
Submission
- Device name
- DW242-07 Non-Precious Alloy F/ Porcelain Fus. Met.
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- February 6, 1992
- Decision date
- March 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was DW242-07 Non-Precious Alloy F/ Porcelain Fus. Met. cleared by the FDA?
DW242-07 Non-Precious Alloy F/ Porcelain Fus. Met. (K920561) received a 510(k) decision of Substantially Equivalent on March 2, 1992, 25 days after the submission was received.
What is the product code of K920561?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.