Alpha-Dent C-R(R) Hybrid Type II Composite Resin
FDA 510(k) K942767 · Wallace A. Erickson & Co.
510(k) numberK942767
Submission
- Device name
- Alpha-Dent C-R(R) Hybrid Type II Composite Resin
- Applicant
- Wallace A. Erickson & Co.
Chicago, IL, US - Received
- June 13, 1994
- Decision date
- July 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K960165 | Alpha-Dent Composite Surface SealantEBF · Traditional | 03/15/1996SE |
| K960122 | Alpha-Dent Temporary Crown and Bridge MaterialEBG · Traditional | 02/21/1996SE |
| K955521 | Alpha-Dent Copal Cavity VarnishLBH · Traditional | 01/24/1996SE |
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| K942742 | Alpha Bond-Rite Ii(Tm) or Bond-Rite Ii(Tm) 2-PASTE AdhevDYH · Traditional | 08/29/1994SE |
| K942727 | Alpha Bound-Rite I No-Mix Adhesive or Bond-Rite I No-Mix AdhesiveDYH · Traditional | 08/23/1994SE |
Questions and answers
When was Alpha-Dent C-R(R) Hybrid Type II Composite Resin cleared by the FDA?
Alpha-Dent C-R(R) Hybrid Type II Composite Resin (K942767) received a 510(k) decision of Substantially Equivalent on July 8, 1994, 25 days after the submission was received.
What is the product code of K942767?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.