Perform Denture Base Resin
FDA 510(k) K871270 · Ipco Corp.
510(k) numberK871270
Submission
- Device name
- Perform Denture Base Resin
- Applicant
- Ipco Corp.
White Plains, NY, US - Received
- March 31, 1987
- Decision date
- May 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Perform Denture Base Resin cleared by the FDA?
Perform Denture Base Resin (K871270) received a 510(k) decision of Substantially Equivalent on May 29, 1987, 59 days after the submission was received.
What is the product code of K871270?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.