SEA2 Self Etch Adhesive
FDA 510(k) K070956 · 3M Espe Dental Products
510(k) numberK070956
Submission
- Device name
- SEA2 Self Etch Adhesive
- Applicant
- 3M Espe Dental Products
St. Paul, MN, US - Received
- April 5, 2007
- Decision date
- May 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SEA2 Self Etch Adhesive cleared by the FDA?
SEA2 Self Etch Adhesive (K070956) received a 510(k) decision of Substantially Equivalent on May 22, 2007, 47 days after the submission was received.
What is the product code of K070956?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.