Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System
FDA 510(k) K050386 · Dentsply International
510(k) numberK050386
Submission
- Device name
- Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System
- Applicant
- Dentsply International
York, PA, US - Received
- February 15, 2005
- Decision date
- February 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System cleared by the FDA?
Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System (K050386) received a 510(k) decision of Substantially Equivalent on February 23, 2005, 8 days after the submission was received.
What is the product code of K050386?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.