Pharmaethyl Local Pulp and Vitality Testing Agent
FDA 510(k) K012427 · Specialites Septodont
510(k) numberK012427
Submission
- Device name
- Pharmaethyl Local Pulp and Vitality Testing Agent
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- July 31, 2001
- Decision date
- October 9, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K913573 | Safety Plus Dental Injection NeedleDZM · Traditional | 11/07/1991SE |
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Questions and answers
When was Pharmaethyl Local Pulp and Vitality Testing Agent cleared by the FDA?
Pharmaethyl Local Pulp and Vitality Testing Agent (K012427) received a 510(k) decision of Substantially Equivalent on October 9, 2001, 70 days after the submission was received.
What is the product code of K012427?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.