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CleaniCal

MARUCHI · Model CleaniCal · UDI-DI 08800071200017

KIF EJK Prescription

510(k) clearances

704

Adverse events

Recalls

Facilities

Description

1. Description: CleaniCal is a type of pre-filled syringe of Calcium Hydroxide Paste with a pH above 12.3. It is applied obturation and intracanal dressings of the root canal following removal of infected or necrotic pulp. It does not replace instrumentation / antibiotics to treat infected canals. 2. Principle of operation: As a prefilled syringe product to quickly and easily dispense calcium hydroxide paste into the root canal, the CleaniCal consists of calcium hydroxide having disinfection effect. It is non-aqueous solvent to be easily dispensed in the root canal as a paste type product, and viscosity agent. 3. Storage conditions: 1) The product must be stored at room temperature avoiding high temperature and humidity. 2) The used 24 gauge tip shall be kept after its metal part cut off. A new 24 gauge tip must be used in next use. 4. Shelf life: 2 years from date of manufacture.

Recalls

Date	Firm	Reason
2016-08-31	Ormco/Sybronendo	SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 20
2009-02-23	Sybron Dental Specialties	Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by pre

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.