Tuff-Temp 2.0
FDA 510(k) K120784 · Pulpdent Corporation
510(k) numberK120784
Submission
- Device name
- Tuff-Temp 2.0
- Applicant
- Pulpdent Corporation
Watertown, MA, US - Received
- March 15, 2012
- Decision date
- June 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Tuff-Temp 2.0 cleared by the FDA?
Tuff-Temp 2.0 (K120784) received a 510(k) decision of Substantially Equivalent on June 8, 2012, 85 days after the submission was received.
What is the product code of K120784?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.