Systemp.Desensitizer (Vivadent.Desensitizer)
FDA 510(k) K003407 · Ivoclar North America, Inc.
510(k) numberK003407
Submission
- Device name
- Systemp.Desensitizer (Vivadent.Desensitizer)
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- November 1, 2000
- Decision date
- January 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Systemp.Desensitizer (Vivadent.Desensitizer) cleared by the FDA?
Systemp.Desensitizer (Vivadent.Desensitizer) (K003407) received a 510(k) decision of Substantially Equivalent on January 26, 2001, 86 days after the submission was received.
What is the product code of K003407?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.