Hermes Bond 2
FDA 510(k) K043043 · 3M Espe AG Dental Products
510(k) numberK043043
Submission
- Device name
- Hermes Bond 2
- Applicant
- 3M Espe AG Dental Products
Bavaria D-82228 Seefeld, DE - Received
- November 4, 2004
- Decision date
- January 10, 2005
- 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 2 cleared by the FDA?
Hermes Bond 2 (K043043) received a 510(k) decision of Substantially Equivalent on January 10, 2005, 67 days after the submission was received.
What is the product code of K043043?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.