BracePaste MTP Light Cure Primer
FDA 510(k) K181910 · American Orthodontics
510(k) numberK181910
Submission
- Device name
- BracePaste MTP Light Cure Primer
- Applicant
- American Orthodontics
Sheboygan, WI, US - Received
- July 17, 2018
- Decision date
- October 15, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BracePaste MTP Light Cure Primer cleared by the FDA?
BracePaste MTP Light Cure Primer (K181910) received a 510(k) decision of Substantially Equivalent on October 15, 2018, 90 days after the submission was received.
What is the product code of K181910?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.