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510(k) Data Aggregation
K Number
K083811Device Name
W&H HANDPIECE ANESTO, MODEL: RA-5
Manufacturer
W & H DENTALWERK BUERMOOS GMBH
Date Cleared
2010-01-14
(388 days)
Product Code
EGM
Regulation Number
872.4475Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.
Device Description
RA-5 "ANESTO" is a handpiece, which, on the one hand, is provided with a coupling system according to ISO 3964. This coupling allows the handpiece's attachment onto a corresponding dental motor, for transmitting the motor's rotational movement to the attached intraosseous injection needle, intended to perforate cortical bone. On the other hand, it was designed for being equipped with an anesthetic cartridge acc. ISO 11499, volume 1.7 or 1.8ml. After having perforated the bone, this cartridge's anesthesia can be administered locally in the spongiosa by means of a manually-operated dosage lever. "ANESTO's" application is intended in dentistry.
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K Number
K964802Device Name
CYBERJET LOCAL ANESTHESIA SYSTEM
Manufacturer
INTRA VANTAGE, INC.
Date Cleared
1997-05-27
(179 days)
Product Code
EGM, DZM
Regulation Number
872.4475Why did this record match?
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Matched: '872.4475'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Administration of intraosseous anesthesia for dental indications.
Device Description
The Cyberjet™ is a dental device intended for intraosseous injection of local anesthetics. Intraosseous injection requires the dentist to drill a small hole in the bone adjacent to the problem tooth. The dentist then uses a standard anesthesia needle and svringe to inject the local anesthetic solution into the previously drilled hole to numb the nerve of the tooth. The Cyberjet™ combines the dental drill and the injection needle into one device and performs both the drilling and injection functions with the same device. After an appropriate injection site has been identified, a topical anesthetic is applied to the gum, followed by a few minutes wait to allow the topical anesthetic to take effect. The previously selected injection site is located and the injection motor and the injection motor are turned on. The tip of the drill/needle is placed on the overlying gum and pressure is applied. The drill/needle passes through the soft tissue and starts to perforate the cortical plate. After the penetration of the cortical plate, the drill motor is turned off by releasing the momentary-switch on the foot-pedal. Local anesthetic is continuously dispensed into the tissue during and after the drilling process through the Infuser. Use of the Cyberjet™ will result in a simple one-step intraosseous injection for dental anesthesia. The system includes 5 components: 1. A Hollow Tubing Needle referred to as a drill/needle or Infuser that serves as a drill as well as a hypodermic iniection needle.
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