Adhese One F
FDA 510(k) K090941 · Ivoclar Vivadent, Inc.
510(k) numberK090941
Submission
- Device name
- Adhese One F
- Applicant
- Ivoclar Vivadent, Inc.
Amherst, NY, US - Received
- April 3, 2009
- Decision date
- July 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Adhese One F cleared by the FDA?
Adhese One F (K090941) received a 510(k) decision of Substantially Equivalent on July 17, 2009, 105 days after the submission was received.
What is the product code of K090941?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.