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510(k) Data Aggregation
K Number
K974670Device Name
ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE
Manufacturer
ATHENA TECHNOLOGY, INC.
Date Cleared
1998-03-13
(88 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ATHENA TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Attachments are used in conjunction with a 20R "E" type slow speed handpiece motor to prepare carious teeth for restorations; to perform prophylaxis or other general procedures performed by the dentist in the oral cavity or in a laboratory environment.
Device Description
Athena nosecones include models to fit "E" type slow speed motors, Midwest and Star slow speed handpiece in two versions, the standard 1:1 non-reduction model and the 4:1 speed reduction model. These have four ball bearing construction; durable stainless steel chuck and operating mechanism. Uses standard handpiece burs, disposable and metal prophy angles.
Athena contra angles include models to fit "E" type slow speed motors and Midwest slow speed handpieces. "E" type models include a standard 1:1 non-reduction model and three speed reduction models 4:1, 16:1 and 64:1. The Midwest version is a 16:1 speed reduction. They convert a straight handpiece to an angle for increased access in the oral cavity. The reduction angles use stainless steel gears and four ball bearings for durability and longevity. Uses latch type heads.
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K Number
K974671Device Name
ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR
Manufacturer
ATHENA TECHNOLOGY, INC.
Date Cleared
1998-03-11
(86 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ATHENA TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use in combination with attachments, i.e., a nosecone or contra angle to prepare carious teeth for restorations; to perform prophylaxis; endodontic preparations or other procedures used by a dentist in the oral cavity.
Device Description
20R "E" type slow speed dental handpiece motor; fully autoclavable (up to 135°C); utilizes an E type coupling to accept standard E type attachments. ISO couplings B, C and D are available.
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