Search Results
Found 1 results
510(k) Data Aggregation
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1