G-Bond
FDA 510(k) K041471 · GC America, Inc.
510(k) numberK041471
Submission
- Device name
- G-Bond
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- June 2, 2004
- Decision date
- June 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K200798 | G-Cem OneEMA · Traditional | 11/24/2020SE |
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Questions and answers
When was G-Bond cleared by the FDA?
G-Bond (K041471) received a 510(k) decision of Substantially Equivalent on June 29, 2004, 27 days after the submission was received.
What is the product code of K041471?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.