Pulpdent Cavity Preparation II, Pulpdent Cavity Preparation II Wuth Fluoride
FDA 510(k) K994181 · Pulpdent Corp.
510(k) numberK994181
Submission
- Device name
- Pulpdent Cavity Preparation II, Pulpdent Cavity Preparation II Wuth Fluoride
- Applicant
- Pulpdent Corp.
Watertown, MA, US - Received
- December 10, 1999
- Decision date
- February 29, 2000
- 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 Cavity Preparation II, Pulpdent Cavity Preparation II Wuth Fluoride cleared by the FDA?
Pulpdent Cavity Preparation II, Pulpdent Cavity Preparation II Wuth Fluoride (K994181) received a 510(k) decision of Substantially Equivalent on February 29, 2000, 81 days after the submission was received.
What is the product code of K994181?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.