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510(k) Data Aggregation
(127 days)
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(194 days)
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(269 days)
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(30 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
BruxZir Shaded 16 PLUS blanks are used for the production of full-contour zirconia and zirconia-based substructures for crowns and bridges (restorations). Multiple thicknesses and shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL3, and White) are available for milling into BruxZir restorations. The manufactured restorations are made utilizing the CAD/CAM system for design and manufacturing. The designed and manufactured restorations are then sintered and glazed. BruxZir Shaded 16 PLUS restorations are designed to match the body shade in the glazed state; however, precolor and stain should be applied if polychromatic (gingival to incisal) blending or other esthetic effects are desired. The sintered material exhibits maximum strength, color, and translucency similar to natural dentition.
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(266 days)
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
The EK Multi Angled 30 Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The EK Multi Angled 30 Abutments are available in various lengths and diameters.
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(421 days)
Multi-Unit DAS System is intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
| Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform Diameter, mm or Name |
|---|---|---|
| Astra Tech EV (Internal Taper) | 3.6 | 3.6 |
| 4.2 | 4.2 | |
| 4.8 | 4.8 | |
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 | Mini |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 | RB/WB |
All digitally designed custom abutments for use with Multi-Unit DAS System are to be sent to a Talladium validated milling center for manufacture.
Multi-Unit DAS System abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration
Multi-Unit DAS system abutments are designed for retention of multi-unit or single-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For all compatible OEM implant lines, the multi-unit abutment components are provided with gingival heights ranging from 1 mm to 4 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm.
This submission includes one (1) abutment level Ti-Base (coping) Engaging Interface for use with the subject multi-unit abutments. The subject Ti-Base (coping) Engaging Interface is a straight prepable design with an additional gingival height of 1.5 mm and a prepable 10.5 mm prosthetic post. This Ti-Base (coping) Engaging Interface has an engaging interface to the multi-unit abutments and is to be used to fabricate a straight final abutment and a straight final restoration. The subject device is identical to the previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559), except the current subject device has an engaging interface. The previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559) is to be used to fabricate a straight final abutment and a straight final restoration.
The subject device multi-unit abutments may be used with the following components, all previously cleared in K231559: Straight Ti-base, non-engaging, part number 35.312.209.21-2; DAS Multi-Unit Engaging Dynamic Ti-Base, part number 31.312.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.21-2; DAS Multi-Unit Healing Cap Regular, part number 40.320.003.88-2; DAS Multi-Unit Healing Cap Wide, part number 40.320.003.89-2; DAS Multi-Unit Dynamic Screw 3.0, part number 41.320.040.01-2; DAS Multi-Unit Provisional Dynamic Screw, part number 41.320.050.02-2; and DAS Multi-Unit Straight Screw, part number 40.320.003.06-2.
No new DAS Multi-Unit Dynamic Ti-Bases are included in this submission. The previously cleared DAS Multi-Unit Dynamic Ti-Base (coping) components (K231599), part numbers 31.312.209.01-2, 31.322.209.01-2, and 31.322.209.21-2 may be used with the subject device Angled Multi-Unit abutments to fabricate a final angled abutment.
A summary of the subject device Multi-Unit DAS System abutment compatibilities with the OEM implants is provided in the following Table 1 Summary of Compatibilities.
Table 1 Summary of Compatibilities
| Compatible Dental Implant Connections | Subject Device: Multi-Unit DAS System |
|---|---|
| Compatible Implant System (Connection) | Implant Body Diameter, mm |
| Astra Tech EV (Internal Taper) | 3.6 |
| 4.2 | |
| 4.8 | |
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | |
| Neodent (Morse taper GM) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 |
| 4.1, 4.8 | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 |
All zirconia superstructures for use with the subject device Multi-Unit DAS system will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the subject Multi-Unit DAS Dynamic Ti-base are:
- Minimum wall thickness – 0.25 mm
- Minimum post height for single-unit restorations – 4.0 mm
(post height measured above the gingival height of the final patient-matched design) - Maximum gingival height – 4.90 mm
- Minimum gingival height – 3.89 mm
- Maximum angulation – 15°
The design parameters for the CAD-CAM zirconia superstructure for the subject device Multi-Unit DAS Ti-Base (coping) Engaging Interface are:
- Minimum wall thickness – 0.25 mm
- Minimum post height for single-unit restorations – 4.0 mm
(post height measured above the gingival height of the final patient-matched design) - Maximum gingival height – 4.90 mm
- Minimum gingival height – 3.89 mm
- Maximum angulation – 0°
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(121 days)
The GBT Machine AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis.
The GBT Machine AIRFLOW Prophylaxis Master is intended for use in the following dental and periodontal applications:
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
The GBT Machine AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the Projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.
The GBT Machine AIRFLOW Prophylaxis Master can be used for the following cleaning procedures:
- plaque removal for placement of sealants
- surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
- surface preparation prior to placing composite restorations
- effective plaque and stain removal for orthodontic patients
- cleaning prior to bonding ortho brackets
- cleaning implant fixture prior to loading
- stain removal for shade determination
- plaque removal prior to fluoride treatment
- plaque and stain removal prior to whitening procedure
The GBT Machine AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The GBT Machine AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The GBT Machine AIRFLOW® Prophylaxis Master is a dental device that combines ultrasonic scaling and air-polishing functions into a single integrated system. It is a modified version of the AIRFLOW Prophylaxis Master previously cleared under 510(k) K190124. The device is compatible with EMS ultrasonic scaling instruments cleared under 510(k) K190124 and with prophylaxis powders including AIRFLOW CLASSIC (K190124), AIR-FLOW PERIO (K190124), and AIR-FLOW PLUS (K171189).
The device is composed of a central control unit, interchangeable handpieces (PIEZON, AIRFLOW, and PERIOFLOW), powder chambers, an irrigation system, and a wireless Bluetooth foot pedal. The control unit contains the power supply, ultrasonic generator, powder and fluid delivery circuits, and a microprocessor control system.
Treatment is activated via the wireless foot pedal, and the control panel allows the clinician to adjust power and irrigation levels. The ultrasonic scaling function operates in the 24-32kHz range using piezoelectric vibration to remove calculus and stains, while the air-polishing function sprays a mixture of air, water, and powder for supragingival and subgingival cleaning.
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(114 days)
The Straumann Variobase Abutments XC for Bridge/Bar are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments XC for Bridge/Bar are indicated for screw-retained or cement-retained bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed in occlusion when the implant is fully osseointegrated.
Straumann Variobase Abutments XC for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations.
The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
The subject Variobase abutments are manufactured from Ti-6Al-7Nb (TAN) and are anodized in violet.
The Variobase Abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations.
The Variobase abutments are provided non-sterile with instructions for end user steam sterilization. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from Ti-6Al-7Nb (TAN). The subject Straumann Variobase Abutments XC for Bridge/Bar is provided in two different platform models, both available with straight and angled screw channel solutions:
Table 10.4.a - Straumann Variobase Abutments XC for Bridge/Bar characteristics
| Platform | Ø (mm) | Gingival heights (mm) | Chimney height (mm) |
|---|---|---|---|
| RB/WB | 3.8 / 4.5 | 1.5 / 2.5 / 3.5 | 7 |
| WB | 5.5 | 0.75 / 1.5 | 7 |
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(115 days)
IPDmilled Blanks are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed CAD/CAM customizations for the IPDmilled Blanks are to be designed and manufactured according to digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, milling machine and associated tooling and accessories. Compatible Implant Systems: Dentium Co., Ltd Implantium, Friadent Implant Systems, Neoss ProActive Implant, SPI® Dental Implant, Inicell®, BEGO Semados® S-Line, ANKYLOS® C/X Implant System, MIS V3 Conical Connection Dental Implant System, Conical Connection Implants (MIS® C1), MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments, PRAMA White Implant Systems, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Straumann TLX Implant System, Kontact Dental Implant System, ICX-Implant System, Tapered Pro Conical Implant System, Straumann® Tissue Level, Zimmer Tapered Screw-Vent®, Nobel Biocare® Nobel Active®, Straumann® Bone Level Tapered Implants, Neodent Implant System – GM Line, Osstem Implant System, Xpeed AnyRidge Internal Implant System, 3i Osseotite® Certain® Dental Implants, Astra Tech Implant System (Osseospeed®), OsseoSpeed™ Plus, BioHorizons Tapered Internal Implant System, MIS Internal Hex Dental Implant System (MIS® Seven®), Straumann BLX Ø3.5 mm Implants, Straumann® BLX Implant System, ALTATEC Camlog Screwline Implant System, Replace TiUnite Endosseous Implant.
The purpose of this submission is to expand abutment categories of IPD Dental Implant Abutments, which were previously cleared.
IPDmilled Blanks is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPDmilled Blanks have a pre-manufactured connection interface that fits directly with a pre-specified dental implant. The customized shape of the abutment is intended to be designed and manufactured according to a digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. IPDmilled Blank is delivered non-sterile and the final restoration, including the screw, is intended to be sterilized at the dental clinic before it is placed in the patient.
The IPDmilled Blanks are blistered together with their specific screw. The screws are intended to attach the prosthesis to the dental implant.
The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".
The design and manufacturing of the custom abutment will be conducted using a digital dentistry workflow requiring the use of the following equipment and software:
Intraoral Scanner: 3Shape TRIOS A/S Series
Desktop Scanner: 3Shape E Series.
Design Software: 3Shape Abutment Designer Software, K151455.
AbutmentCAD, K193352.
Milling unit: CORiTEC 350i PRO / CORiTEC 350i Loader PRO with MillBox CAM software.
IPDmilled Blank libraries' have built-in design limitations, and the user isn't allowed to exceed these limitations. The custom abutment design limitation specifications are as follows:
Minimum gingival height: 0.5 mm
Maximum gingival height: 6.0 mm
Minimum wall thickness: 0.4 mm
Minimum post height: 4.0 mm
All IPDmilled Blanks are for straight abutments only.
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(1 days)
LumiCera is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges.
The product should be used in combination with SHINING3D printer. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by photoinitiator contained in the resin. The resin is printed in multiple layers automatically, with each layer being subjected to light curing before the addition of the next layer, and then undergoes post-curing in a curing device. The product is intended exclusively for professional dental work.
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