ADH19
FDA 510(k) K192961 · 3M Deutschland GmbH
510(k) numberK192961
Submission
- Device name
- ADH19
- Applicant
- 3M Deutschland GmbH
Seefeld, DE - Received
- October 22, 2019
- Decision date
- October 31, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was ADH19 cleared by the FDA?
ADH19 (K192961) received a 510(k) decision of Substantially Equivalent on October 31, 2019, 9 days after the submission was received.
What is the product code of K192961?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.