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510(k) Data Aggregation
K Number
K984244Device Name
ORL-E-92 SURGICAL DRILL SYSTEM
Manufacturer
BIEN AIR USA, INC.
Date Cleared
1999-02-23
(88 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
BIEN AIR USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bien-Air ORL-E-92 Surgical Drill System is indicated for the preparation of intraoral bone for microsurgery and implantology and for apicoectomies.
Device Description
The Bien-Air ORL-E-92 Surgical Drill System is a series of components used in implantology and microsurgery. The system consists of a foot pedal control unit, BASCH electric micromotor and cable and transformer. Several models of straight and contra-angled microsurgery handpieces are available for use with the ORL-E-92 system. A separate irrigation system consisting of peristaltic pump, irrigation tubing and solution supports complements the ORL-E-92 system.
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K Number
K983183Device Name
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
Manufacturer
BIEN AIR USA, INC.
Date Cleared
1998-12-10
(90 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
BIEN AIR USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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