ACTIVA PRESTO PACK— 510(k) K210045

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K210045 for ACTIVA PRESTO PACK, Substantially Equivalent on 2021-09-22. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant: Pulpdent Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2021-01-08
Decision date: 2021-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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More clearances from Pulpdent Corporation

K173020 — OBA-MCP, Orthodontic Bracket Adhesive with MCP2018-01-17
K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP2018-01-05
K153249 — Pulpdent Solo Flowable Composite with MCP2016-04-01
K130223 — RMGI FILL2013-03-29
K123265 — RMGI LOW VISCOSITY2012-12-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.