Granitec Ionomer Resin Cement
FDA 510(k) K940546 · Confi-Dental Products Co.
510(k) numberK940546
Submission
- Device name
- Granitec Ionomer Resin Cement
- Applicant
- Confi-Dental Products Co.
Louisville, CO, US - Received
- February 7, 1994
- Decision date
- April 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Granitec Ionomer Resin Cement cleared by the FDA?
Granitec Ionomer Resin Cement (K940546) received a 510(k) decision of Substantially Equivalent on April 29, 1994, 81 days after the submission was received.
What is the product code of K940546?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.