Hermes Bond
FDA 510(k) K033974 · 3M Espe AG Dental Products
510(k) numberK033974
Submission
- Device name
- Hermes Bond
- Applicant
- 3M Espe AG Dental Products
Bavaria D-82228 Seefeld, DE - Received
- December 22, 2003
- Decision date
- February 6, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Hermes Bond cleared by the FDA?
Hermes Bond (K033974) received a 510(k) decision of Substantially Equivalent on February 6, 2004, 46 days after the submission was received.
What is the product code of K033974?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.