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510(k) Data Aggregation
K Number
K140347Device Name
ANKYLOS C/X IMPLANT SYSTEM
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2014-08-20
(190 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
Device Description
The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.
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K Number
K130862Device Name
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2013-07-23
(117 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for:
- . Stain removal,
- Prophylaxis of orthodontic patients, .
- Preparing tooth surfaces prior to bonding and sealant procedures, and ●
- Implant debridement .
Device Description
The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is an air polishing unit that delivers an air/water/powder mixture at the air polishing insert tip that polishes the tooth enamel without direct contact of the device. The system is used with water-soluble prophy powders such as Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342) or Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188) (for patients with low sodium requirements). Updated design features on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System include a Tap-On™ Wireless Foot Pedal, prophy mode auto cycles, an illuminated diagnostic display, automated purge function, Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697), and a swivel handpiece cable with more precise lavage control. Upon installation, the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System unit is connected to external air and water lines, as well as an AC power cord.
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K Number
K123615Device Name
IRIS - HIGH STRENGTH GLASS CERAMIC
Manufacturer
DENTSPLY INTL.
Date Cleared
2013-02-22
(91 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IRIS - High Strength Glass Ceramic is a system of precrystallized and/or fully crystallized zirconia reinforced lithium silicate glass ceramics and veneering ceramics processed through CAD-CAM techniques for the fabrication of: Single unit dental restorations, for example all-ceramic crowns, inlays, onlays and veneers. IRIS can be used as a substructure which is then veneered with IRIS veneering ceramic or can be used for full-contour application (without veneering) as well.
Device Description
IRIS - High Strength Glass Ceramic is a system of glass ceramic dental materials based on zirconia reinforced lithium silicate chemistries and feldspathic veneering ceramics and accessories optimized to be compatible with IRIS glass ceramics. The system consists of: A. IRIS Flex: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the fully crystallized state, for machining and subsequent placement. B. IRIS CAD: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the partially crystallized state, for machining, crystallization firing, and subsequent placement. C. Veneering ceramics provided in powder/paste forms and are intended for optional esthetic characterization of the CAD CAM restorations. IRIS materials may be veneered with a compatible dental veneering ceramic or can be used as anatomically shaped full-contour restorations without veneering.
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K Number
K103244Device Name
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2011-02-14
(104 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.
Device Description
QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation.
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K Number
K093221Device Name
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2009-10-30
(17 days)
Product Code
DYH, EJF, NJM
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Device Description
The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives.
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K Number
K083805Device Name
ANKYLOS C/X DENTAL IMPLANT SYSTEM
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2009-05-22
(151 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
Device Description
The new ANK YLOS® C/X Dental Implant System introduces a new configuration of the current ANKYLOS® plus dental implant line. The new line extension includes the: ANKYLOS® C/X Implant, ANK YLOS C/ Regular Abutments, ANKYLOS /X Regular Abutments, ANKYLOS® Regular C/X Gingiva Former, and the ANK YLOS® Titanium Alloy Screws (Membrane Screw and Fixation Screw). The ANKYLOS® C/X Dental Implant was modified to integrate an indexation into the taper connection to provide a precise position of the abutment. With the new index, the relocation of the abutment is possible without using a transfer-kev for the impressions taking.
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K Number
K082198Device Name
DURASHIELD PLUS
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2008-10-29
(86 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.
Device Description
DURASHIELD® PLUS is a topically applied, flavored cavity varnish containing sodium fluoride and NovaMin. The varnish is a viscous liquid and is insoluble in water and saliva. NovaMin is a bio-available calcium phosphosilicate that releases calcium and phosphorous when exposed to moisture.
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K Number
K072730Device Name
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
Manufacturer
DENTSPLY INTL.
Date Cleared
2008-03-27
(183 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue.
The ANK YLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.
Device Description
The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics.
The CERCON® ABUTMENTS are available as straight and angled abutments with different gingival margins and in multiple diameters and shades.
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K Number
K072989Device Name
AXIS SYSTEM
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2008-01-28
(97 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axis System is an air-powered dental handpiece system indicated for use in general dentistry.
Device Description
The Axis System consists of air-powered dental handpieces with an electronic accessory to limit the speed.
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K Number
K073117Device Name
DENTIN DESENSITIZER AGENT
Manufacturer
DENTSPLY INTL., INC.
Date Cleared
2007-12-19
(44 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
DENTSPLY INTL., INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
Device Description
The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.
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