Belleglaze
FDA 510(k) K992067 · Kerr Dental Materials Center
510(k) numberK992067
Submission
- Device name
- Belleglaze
- Applicant
- Kerr Dental Materials Center
Orange, CA, US - Received
- June 18, 1999
- Decision date
- August 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K014027 | Optibond Solo Plus 4KLE · Traditional | 02/22/2002SE |
| K013375 | Belleglass HP Opaque 2EBF · Traditional | 10/29/2001SE |
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Questions and answers
When was Belleglaze cleared by the FDA?
Belleglaze (K992067) received a 510(k) decision of Substantially Equivalent on August 27, 1999, 70 days after the submission was received.
What is the product code of K992067?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.