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510(k) Data Aggregation
K Number
K183018Device Name
VPro5
Manufacturer
Date Cleared
2019-11-01
(366 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Propel Orthodontics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VPro5® is intended for use by the orthodontic patient during treatment with aligners to facilitate minor anterior tooth movement.
Device Description
The VPro5® is a rechargeable, hand-held, powered, high-frequency vibration device. The device consists of the following components: the VPro5 Oscillator, the VPro5 Mouthpiece, a charging cable, and a wall charging adapter. The oscillator and mouthpiece are coupled together prior to use. During use, the C-shaped mouth piece adapter is manually applied to the occlusal surface of the teeth. The VPro5® is to be used 5 minutes per day in a single session in conjunction with aligner orthodontic treatment. The mouthpiece is connected to the oscillator and turned on by depressing a white on-switch located on the unit. When turned on the device will slowly ramp up to full vibration frequency of 120Hz. The vibrations are applied to the occlusal surface of the teeth. The device will automatically shut off after a duration of 5 minutes. The oscillator also contains LED light notifications which indicate status of the cycle progression. The mouthpiece is to be cleaned and stored in a dry place. The USB port can also be connected to a computer to display usage data.
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K Number
K172164Device Name
PROPEL Device
Manufacturer
Date Cleared
2018-01-17
(183 days)
Product Code
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
Propel Orthodontics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PROPEL Device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including: (1) initiation holes for drill bits, implants, screws, plates, and other orthodontic appliances; and (2) for use as a tool to create micro-osteoperforations.
Device Description
The PROPEL Device has a stainless steel drill tip with an outer diameter (drill bit OD) of 1.6 mm that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth (0, 3, 5, or 7 mm), thus preventing the drill tip from penetrating the bone beyond the targeted depth when used for osteotomies during dental operative procedures. The handle contains the red LED operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.
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K Number
K150392Device Name
PROPEL device
Manufacturer
Date Cleared
2015-09-18
(212 days)
Product Code
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
PROPEL ORTHODONTICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.
Device Description
The PROPEL Device is intended for use in dental operative procedures involving the preparation of tissue and bone. The PROPEL Device can be used manually as a bone cutting instrument in accordance with the FDA regulation 21 CFR Sec. 872.4120. It CANNOT be attached to any powered driver.
The PROPEL Device has a stainless steel drill tip that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth at 3. 5. or 7mm, thus preventing the drill tip from penetrating the bone bevond the targeted depth when used during orthodontic and dental operative procedures. The handle contains a red LED. operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.
The device is provided sterile and is for single use only.
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