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510(k) Data Aggregation
K Number
K023953Device Name
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
Manufacturer
Date Cleared
2003-02-14
(79 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ST. GEORGE TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a plastic disposable attachment for use in conjunction with a slow speed handpiece, used during the professional prophylaxis treatment of patient's teeth by a dentist or hygienist.
Our disposable prophylaxis angle is intended as a single use device used by a Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and should be discarded after each patient.
Device Description
Plastic disposable item comprising a housing (body) that holds two plastic shafts aligned at 90 degrees (right angle) to each other that rotate a cup or brush.
Plastic one-piece housing (outer body) holding 2 internal shafts aligned at 90 degree (right angle) to each other. Tip fitted with a rubber cup or brush to clean teeth.
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K Number
K992176Device Name
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
Manufacturer
Date Cleared
2000-02-10
(227 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
ST. GEORGE TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Excel Ultra-Hi Formula Heat-Cured Denture Base material is indicated for use in the fabrication, repairing, relining and/or rebasing of full or partial removable prosthetic devices.
Device Description
Excel Ultra-Hi Formula Heat-Cured Denture Base
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