Prime&Bond Elect Universal Dental Adhesive
FDA 510(k) K151619 · Dentsply International, Inc.
510(k) numberK151619
Submission
- Device name
- Prime&Bond Elect Universal Dental Adhesive
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- June 16, 2015
- Decision date
- October 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Prime&Bond Elect Universal Dental Adhesive cleared by the FDA?
Prime&Bond Elect Universal Dental Adhesive (K151619) received a 510(k) decision of Substantially Equivalent on October 30, 2015, 136 days after the submission was received.
What is the product code of K151619?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.