Futura Glass Ionomer Silver Reinforced
FDA 510(k) K991974 · Ab Ardent
510(k) numberK991974
Submission
- Device name
- Futura Glass Ionomer Silver Reinforced
- Applicant
- Ab Ardent
Tonawanda, NY, US - Received
- June 11, 1999
- Decision date
- September 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Futura Glass Ionomer Silver Reinforced cleared by the FDA?
Futura Glass Ionomer Silver Reinforced (K991974) received a 510(k) decision of Substantially Equivalent on September 17, 1999, 98 days after the submission was received.
What is the product code of K991974?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.