Pulpdent Edta Preparations
FDA 510(k) K932791 · Pulpdent Corp.
510(k) numberK932791
Submission
- Device name
- Pulpdent Edta Preparations
- Applicant
- Pulpdent Corp.
Watertown, MA, US - Received
- June 9, 1993
- Decision date
- September 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Pulpdent Edta Preparations cleared by the FDA?
Pulpdent Edta Preparations (K932791) received a 510(k) decision of Substantially Equivalent on September 20, 1993, 103 days after the submission was received.
What is the product code of K932791?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.