Excel Bond DC, Model 28-200100
FDA 510(k) K060882 · J. Morita USA, Inc.
510(k) numberK060882
Submission
- Device name
- Excel Bond DC, Model 28-200100
- Applicant
- J. Morita USA, Inc.
Irvine, CA, US - Received
- March 31, 2006
- Decision date
- September 1, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Excel Bond DC, Model 28-200100 cleared by the FDA?
Excel Bond DC, Model 28-200100 (K060882) received a 510(k) decision of Substantially Equivalent on September 1, 2006, 154 days after the submission was received.
What is the product code of K060882?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.