Quell Desensitizer
FDA 510(k) K010957 · Jeneric/Pentron, Inc.
510(k) numberK010957
Submission
- Device name
- Quell Desensitizer
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- March 30, 2001
- Decision date
- June 25, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K011362 | Gold Core 73 LSEJT · Traditional | 05/29/2001SE |
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Questions and answers
When was Quell Desensitizer cleared by the FDA?
Quell Desensitizer (K010957) received a 510(k) decision of Substantially Equivalent on June 25, 2001, 87 days after the submission was received.
What is the product code of K010957?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.