Microdose Potassium Oxylate
FDA 510(k) K924827 · Unicep
510(k) numberK924827
Submission
- Device name
- Microdose Potassium Oxylate
- Applicant
- Unicep
Sandpoint, ID, US - Received
- September 28, 1992
- Decision date
- March 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K924821 | Microdose Porcelain EtchantELL · Traditional | 03/16/1993SE |
| K924826 | Microdose Total EtchantEBF · Traditional | 03/05/1993SE |
| K924825 | Microdose Rc-EzEKM · Traditional | 03/05/1993SE |
| K924822 | Microdose Enamel EtchantEBF · Traditional | 03/05/1993SE |
Questions and answers
When was Microdose Potassium Oxylate cleared by the FDA?
Microdose Potassium Oxylate (K924827) received a 510(k) decision of Substantially Equivalent on March 5, 1993, 158 days after the submission was received.
What is the product code of K924827?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.