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510(k) Data Aggregation
K Number
K973539Device Name
ROEKO CALCIUM HYDROXIDE POINTS
Manufacturer
ROEKO USA, INC.
Date Cleared
1997-10-30
(42 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
ROEKO USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For calcium hydroxide root canal therapy either prior to or after root career industration for emergency root canal there prior for treatment of root resorptions: and for early still and area root canar preparation; for emergency root canal treat. for treatment of root resorptions; and for early childhood trauma.
Device Description
The Roeko Calcium Hydroxide Points are deposit preparations which release calcium hydroxide from a gutta percha matrix. The device consists of calcium hydroxide, gutta percha, barium sulfate, stearic acid, and colorants.
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