Activa Presto Pack
FDA 510(k) K210045 · Pulpdent Corporation
510(k) numberK210045
Submission
- Device name
- Activa Presto Pack
- Applicant
- Pulpdent Corporation
Watertown, MA, US - Received
- January 8, 2021
- Decision date
- September 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K130223 | Rmgi FillEMA · Traditional | 03/29/2013SE |
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Questions and answers
When was Activa Presto Pack cleared by the FDA?
Activa Presto Pack (K210045) received a 510(k) decision of Substantially Equivalent on September 22, 2021, 257 days after the submission was received.
What is the product code of K210045?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.