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510(k) Data Aggregation
K Number
K090457Device Name
ORALUBE
Manufacturer
PULPDENT CORPORATION
Date Cleared
2009-05-21
(87 days)
Product Code
ONK
Regulation Number
880.6375Why did this record match?
Product Code :
ONK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OraLube is a water-soluble, viscous liquid coating intended to be used an intraoral and perioral release agent for the following clinical situations:
- Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material;
- Using a dental cement or adhesive, in which OraLube is applied to adjacent hard and soft tissue and to the lips and skin around the mouth to prevent adherence of the cement or adhesive;
- Placement of a rubber dam, in which OraLube is brushed on the tooth to facilitate slipping the rubber dam over it.
- Long procedures, in which OraLube can be used to protect the lips from drying out and cracking.
Device Description
Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent, slip agent, lubricant, lip and skin protector.
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