Luxaglaze
FDA 510(k) K013179 · Dmg USA, Inc.
510(k) numberK013179
Submission
- Device name
- Luxaglaze
- Applicant
- Dmg USA, Inc.
Dover, DE, US - Received
- September 24, 2001
- Decision date
- October 12, 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 Luxaglaze cleared by the FDA?
Luxaglaze (K013179) received a 510(k) decision of Substantially Equivalent on October 12, 2001, 18 days after the submission was received.
What is the product code of K013179?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.