Isodan
FDA 510(k) K010415 · Specialites Septodont
510(k) numberK010415
Submission
- Device name
- Isodan
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- February 12, 2001
- Decision date
- July 23, 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 Isodan cleared by the FDA?
Isodan (K010415) received a 510(k) decision of Substantially Equivalent on July 23, 2001, 161 days after the submission was received.
What is the product code of K010415?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.