Apex Universal Adhesive
FDA 510(k) K131043 · Apex Dental Materials, Inc.
510(k) numberK131043
Submission
- Device name
- Apex Universal Adhesive
- Applicant
- Apex Dental Materials, Inc.
Lake Zurich, IL, US - Received
- April 15, 2013
- Decision date
- September 10, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Apex Universal Adhesive cleared by the FDA?
Apex Universal Adhesive (K131043) received a 510(k) decision of Substantially Equivalent on September 10, 2013, 148 days after the submission was received.
What is the product code of K131043?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.