Model SK-14 Starter Kit for Dental Iontophoresis
FDA 510(k) K872039 · Life-Tech Intl., Inc.
510(k) numberK872039
Submission
- Device name
- Model SK-14 Starter Kit for Dental Iontophoresis
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- May 27, 1987
- Decision date
- November 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
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Questions and answers
When was Model SK-14 Starter Kit for Dental Iontophoresis cleared by the FDA?
Model SK-14 Starter Kit for Dental Iontophoresis (K872039) received a 510(k) decision of Substantially Equivalent on November 13, 1987, 170 days after the submission was received.
What is the product code of K872039?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.