Submission Details
| 510(k) Number | K242559 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 28, 2024 |
| Decision Date | November 26, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
Digital Temp
Nov 2024
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K242559 is an FDA 510(k) clearance for the Digital Temp, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 26, 2024, 90 days after receiving the submission on August 28, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.
Device Classification
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3770 |
Manufacturer
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