GingiDent Gingival Retraction Paste
K-Number: K162662 · 2017-10-20
ApplicantPac-Dent International, Inc.
Decision Date2017-10-20
Product CodeMVL
DecisionSubstantially Equivalent
Device Summary
GingiDent Gingival Retraction Paste is a medical device manufactured by Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2017-10-20 under approval number K162662. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GingiDent Gingival Retraction Paste?
GingiDent Gingival Retraction Paste is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Pac-Dent International, Inc.. The 510(k) number is K162662.
When was GingiDent Gingival Retraction Paste approved by the FDA?
GingiDent Gingival Retraction Paste received FDA 510(k) clearance on 2017-10-20, under approval number K162662.
What company makes GingiDent Gingival Retraction Paste?
GingiDent Gingival Retraction Paste is manufactured by Pac-Dent International, Inc..
What is the FDA product code for GingiDent Gingival Retraction Paste?
The FDA product code for GingiDent Gingival Retraction Paste is MVL.
Other Devices by Pac-Dent International, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.