Alpha-Dent Pit and Fissure Sealant
FDA 510(k) K924635 · Wallace A. Erickson & Co.
510(k) numberK924635
Submission
- Device name
- Alpha-Dent Pit and Fissure Sealant
- Applicant
- Wallace A. Erickson & Co.
Chicago, IL, US - Received
- August 24, 1992
- Decision date
- October 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K960122 | Alpha-Dent Temporary Crown and Bridge MaterialEBG · Traditional | 02/21/1996SE |
| K955521 | Alpha-Dent Copal Cavity VarnishLBH · Traditional | 01/24/1996SE |
| K955089 | Alpha-Dent Zinc Oxide Eugenol Temporary CementEMA · Traditional | 12/13/1995SE |
| K942742 | Alpha Bond-Rite Ii(Tm) or Bond-Rite Ii(Tm) 2-PASTE AdhevDYH · Traditional | 08/29/1994SE |
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Questions and answers
When was Alpha-Dent Pit and Fissure Sealant cleared by the FDA?
Alpha-Dent Pit and Fissure Sealant (K924635) received a 510(k) decision of Substantially Equivalent on October 16, 1992, 53 days after the submission was received.
What is the product code of K924635?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.