Vertex L/C Orthodontic Direct Bonding Paste
FDA 510(k) K010544 · Apex Dental Materials, Inc.
510(k) numberK010544
Submission
- Device name
- Vertex L/C Orthodontic Direct Bonding Paste
- Applicant
- Apex Dental Materials, Inc.
Schaumburg, IL, US - Received
- February 23, 2001
- Decision date
- August 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vertex L/C Orthodontic Direct Bonding Paste cleared by the FDA?
Vertex L/C Orthodontic Direct Bonding Paste (K010544) received a 510(k) decision of Substantially Equivalent on August 10, 2001, 168 days after the submission was received.
What is the product code of K010544?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.