Dentaurum Mix Two-Paste Bracket Adhesive
FDA 510(k) K030977 · Dentaurum
510(k) numberK030977
Submission
- Device name
- Dentaurum Mix Two-Paste Bracket Adhesive
- Applicant
- Dentaurum
Newtown, PA, US - Received
- March 28, 2003
- Decision date
- August 25, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K030644 | Contec Duo, Contec LC, Contec LCRDYH · Traditional | 11/21/2003SE |
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| K030641 | Contec LightEBZ · Traditional | 06/10/2003SE |
| K011428 | TriceramEIH · Traditional | 06/05/2001SE |
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Questions and answers
When was Dentaurum Mix Two-Paste Bracket Adhesive cleared by the FDA?
Dentaurum Mix Two-Paste Bracket Adhesive (K030977) received a 510(k) decision of Substantially Equivalent on August 25, 2003, 150 days after the submission was received.
What is the product code of K030977?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.