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510(k) Data Aggregation
K Number
K981869Device Name
PRO-FLEX DISPOSABLE PROPHY ANGLE
Manufacturer
Date Cleared
1998-08-11
(75 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PROFESSIONAL DENTAL MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For one time use as part of a professionally administered prophylaxis treatment, to clean and polish teeth.
Device Description
The device is a disposable dental prophylaxis angle which consists of a plastic body integrally formed with a drive mechanism, and a rubber cup that attaches to a retention knob or stud on the angle. The prophy angle has a slot for connecting the angle to a dental handpiece, which powers the prophy angle. The drive shaft of the prophy angle allows the rubber prophy cup to rotate.
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K Number
K964596Device Name
PROSELECT 3 PERIDONTAL THERAPY SYSTEM
Manufacturer
Date Cleared
1997-04-22
(155 days)
Product Code
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
PROFESSIONAL DENTAL MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
Device Description
an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
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