Pulpdent (Activa) Pit and Fissure Sealant with MCP— 510(k) K172169

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K172169 for Pulpdent (Activa) Pit and Fissure Sealant with MCP, Substantially Equivalent on 2018-01-05. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant
Pulpdent Corporation
Product code
Code EBC
Device class
Class 2
Regulation
21 CFR 872.3765
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Watertown, MA, US
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