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510(k) Data Aggregation
K Number
K990546Device Name
DELSONIC 2000
Manufacturer
Date Cleared
1999-11-05
(256 days)
Product Code
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SDS DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DELSONIC 2000 Ultrasonic Scaler is intended to be used fast and reliable removal of light to heavy calculus and plaque. This 29kHz ultrasonic system provides automatic tuning for each scaling insert.
Device Description
The DELSONIC 2000 is an automatically tuned piezo ultrasonic scaler that generates linear tip movement at 29kHz for efficient, yet gentle calculus removal. The DELSONIC piezo ultrasonic scaler is designed for the prevention of crossinfection with fully autoclavable handpiece sleeves sterlisible removable control knobs and wipe clean display panel
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K Number
K990545Device Name
JETSONIC 2000
Manufacturer
Date Cleared
1999-08-11
(170 days)
Product Code
Regulation Number
872.6080Why did this record match?
Applicant Name (Manufacturer) :
SDS DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This unit combines both ultrasonic scaling and airpolishing functions in one compact unit that answers all prophylaxis needs. The air polishing function is intended to be used to remove stubbern stains, plaque and soft debris. The scaler funtions is intended to be used for cauculus removal. Device applications: Routine oral prophylaxis, routine polishing especially in hard to reach fissures and interproximal areas, prior to enamel etching and bonding techiniques and prior to bonding orthodontic bands and brackets.
Device Description
Jetsonic 2000 combines both ultrasonic scalling and air polishing functions in one compact unt that answers all prophylaxis needs.
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K Number
K964619Device Name
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
Manufacturer
Date Cleared
1997-01-22
(65 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
SDS DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures.
Device Description
The 1400 XL Deluxe Dental Delivery System is designed to conveniently position the dentist's dynamic instruments for use during dental procedures. The arm system the control head is affixed to consists of three pieces. The first section is a rigid arm that mounts on a two inch outside diameter post. Attached to the end of the rigid arm section is a flex arm section that allows for vertical positioning. The flex arm section contains a pneumatic brake that helps provide positive positioning. The third piece is a control mount that allows flexibility in the horizontal positions. The delivery system provides connections for three pneumatically operated instruments. The common instrument used is the dental handpiece. The unit provides automatic instrument selection by means of a three way pneumatic valve located in each instrument hanger assembly. The automatic selection takes place when a static air pressure signal is removed from the top of a diaphragm located in the handpiece control block. The actual activation of the instrument is initiated by pressing on a foot containing a three way pneumatic valve. The delivery system also provides an air and water syringe for use as the dental procedure may require. The air and water syringe has an autoclavable syringe tip. The control also houses a master on/off control. air volume adjustments for the pneumatic instruments, water coolant volume adjustments, flex arm brake toggle, and an air coolant volume adjustment. There is also a toggle valve located on the control that allows for water purging of the water coolant lines that supply the pneumatic instruments with water coolant. The air and water utilities are are supplied through polyurethane tubing housed in a flexible umbilical.
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