Alpha-Dent Tissue Conditioner and Temporary Reliner
FDA 510(k) K934248 · Wallace A. Erickson & Co.
510(k) numberK934248
Submission
- Device name
- Alpha-Dent Tissue Conditioner and Temporary Reliner
- Applicant
- Wallace A. Erickson & Co.
Chicago, IL, US - Received
- August 30, 1993
- Decision date
- December 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 Tissue Conditioner and Temporary Reliner cleared by the FDA?
Alpha-Dent Tissue Conditioner and Temporary Reliner (K934248) received a 510(k) decision of Substantially Equivalent on December 8, 1993, 100 days after the submission was received.
What is the product code of K934248?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.