Pac-Dent Ceramic Nanohybrid Resin
FDA 510(k) K210412 · Pac-Dent, Inc.
510(k) numberK210412
Submission
- Device name
- Pac-Dent Ceramic Nanohybrid Resin
- Applicant
- Pac-Dent, Inc.
Brea, CA, US - Received
- February 11, 2021
- Decision date
- July 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Pac-Dent Ceramic Nanohybrid Resin cleared by the FDA?
Pac-Dent Ceramic Nanohybrid Resin (K210412) received a 510(k) decision of Substantially Equivalent on July 26, 2021, 165 days after the submission was received.
What is the product code of K210412?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.