GC Temp Print
FDA 510(k) K193113 · GC America, Inc.
510(k) numberK193113
Submission
- Device name
- GC Temp Print
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- November 12, 2019
- Decision date
- July 9, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 11/26/2024SE |
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Questions and answers
When was GC Temp Print cleared by the FDA?
GC Temp Print (K193113) received a 510(k) decision of Substantially Equivalent on July 9, 2020, 240 days after the submission was received.
What is the product code of K193113?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.