Search Results
Found 13 results
510(k) Data Aggregation
K Number
K092614Device Name
X-SMART EASY
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2009-12-02
(98 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).
Device Description
The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.
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K Number
K092030Device Name
ELATION MB METAL REINFORCED PLASTIC BRACKET
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2009-07-24
(18 days)
Product Code
DYW
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Elation MB metal reinforced plastic brackets is indicated for orthodontic movement of natural teeth.
Device Description
The marketed product Elation Metal Reinforced Plastic Brackets has a barrel polished bonding base. A modification has been made to replace the base with the previously tested mechanical lock base and an improvement in the tie wing, Elation MB Metal Reinforced Plastic Brackets.
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K Number
K090454Device Name
ALLURE MB CERAMIC BRACKETS
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2009-03-20
(25 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.
Device Description
The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.
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K Number
K082973Device Name
STER-MATE STERILE LAVAGE KIT
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2009-01-29
(115 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery.
Device Description
The Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit is an accessory for Cavitron® Ultrasonic Scalers that use the 30K Steri-Mate® Sterilizable Handpiece. This kit is intended to provide the clinician with a method to use sterile lavage with a Cavitron® Ultrasonic Scaler. The kit consists of a pressurized infuser bag and a Steri-Mate Handpiece Adapter. The Pressurized Infuser bag can be hung from a standard IV pole or similar device. The Steri-Mate Handpiece Adapter is easily installed between the handpiece cable and the Steri-Mate Handpiece. The adapter does not affect the operation of the Cavitron® Unit or the Steri-Mate Handpiece.
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K Number
K082974Device Name
MYSTIQUE MB CERAMIC BRACKETS
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-11-07
(32 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Device Description
The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. The modification to the Orthodontic Ceramic Bracket consists of a mechanical lock base and the brackets: are referred to as the Mystique MB Ceramic Brackets. Mystique MB Ceramic Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The mechanical lock base includes rhomboid and "torque-in-the-base" features. The bracket is transparent and has indented walls and is available with or without glass coating in the wire slot.
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K Number
K081291Device Name
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-05-22
(15 days)
Product Code
DYH, EJF, NJM
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Device Description
The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).
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K Number
K080311Device Name
MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-04-18
(72 days)
Product Code
EBG, EBD
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified TempRx Esthetic Provisional System is:
- · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months.
- · Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years:
- Inlays/ Onlays
- Veneers
- Crowns
- 3-unit bridges through the 2nd bicuspid.
· Indicated for the build up of a tooth on denture base resins.
Device Description
The Modified TempRx Esthetic Provisional System is a visible light cured composite based resin and accessories used to create provisional restorations for patients waiting for final prosthodonic restorations.
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K Number
K080246Device Name
COMPOSITE ALIGNER BUTTON
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-04-11
(71 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
Device Description
The COMPOSITE ALIGNER BUTTON is made of plastic and is bonded to an aligner for attaching elastics and other appliances.
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K Number
K080203Device Name
MTA ROOT CANAL SEALER
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-03-26
(58 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MTA ROOT CANAL SEALER is indicated for use for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials.
Device Description
The MTA ROOT CANAL SEALER is a powder and liquid root canal sealer system. The combination of the powder and liquid creates a colloidal gel that solidifies to form a strong impermeable barrier to seal off pathways of communication between the root canal system and external surfaces of the tooth.
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K Number
K073173Device Name
SELF-ADHESIVE RESIN CEMENT
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-01-23
(71 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTERNTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.
Device Description
Self-adhesive Resin Cement consists of a base paste and a catalyst paste, mixed to form a dual-curing cement. The Cement is available in five shades and is delivered in double-barrel syringes and unit dose systems.
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