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510(k) Data Aggregation
K Number
K102639Device Name
SL3
Manufacturer
DISCUS DENTAL, LLC
Date Cleared
2010-12-01
(78 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions.
The SL3 laser is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SL3 laser is intended for ablating, incising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
Device Description
The SL3™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAIAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. The SL3™ is designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures.
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K Number
K101612Device Name
ZEN CORDLESS PROPHY SYSTEM
Manufacturer
DISCUS DENTAL, LLC
Date Cleared
2010-06-30
(21 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.
Device Description
The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.
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K Number
K101215Device Name
NUANCE
Manufacturer
DISCUS DENTAL, LLC
Date Cleared
2010-05-12
(12 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nuance Universal Composite:
- Direct restorations of anterior or posterior teeth (Class I Class V) .
- Diastema closures .
- Intraoral repairs of fractured crowns/bridges ●
Nuance Posterior Composite:
- Direct restorations of Class I and Class II cavities .
Nuance Flowable Composite:
- Direct restorations of anterior or posterior teeth .
- Cavity base/liner .
- Intraoral repairs of fractured crowns/bridges .
Device Description
Not Found
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K Number
K093208Device Name
SIMPLISEAL
Manufacturer
DISCUS DENTAL, LLC
Date Cleared
2010-02-12
(122 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). SimpliSeal is intended for use by qualified healthcare personnel trained in its use.
Device Description
SimpliSeal is a root canal sealer delivered in a dual-barrel syringe. This epoxy based resin sealer is easy to use with gutta-percha points and can also be used with established and more recent root canal sealing techniques. SimpliSeal with colaonent obturation of root canals when combined with obturation points.
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K Number
K092417Device Name
INSIGHT ULTRASONIC INSERTS
Manufacturer
DISCUS DENTAL, LLC
Date Cleared
2009-12-11
(126 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.
Device Description
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and performs the instrumentation. The tips are offered in two frequencies, six different colors and twenty different tip styles.
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