(450 days)
The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abulment;
- Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
- Abutment Screws to permanently fix the abutments to the Implant.
Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
Core 3D abutments and are compatible for use with the following dental implants: - Nobel Biocare Branemark System (K022562, K934825)
- Zimmer Tapered Screwvent (K013227, K061410, K072589)
The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations.
The system is composed of the following principal components:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
- Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques
- Abutment Screws: to fix abutments to the underlying dental implant.
The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system: - CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer
- Scanner: 3Shape D810 model
- Milling machine: SAUER HSC-20 DMG.
Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CORE 3D Abutment System for Digital Prosthetic Solutions:
Important Note: The provided document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing entirely new safety and efficacy data through clinical trials. As such, the information you've requested regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies might not be explicitly present in the way it would be for a novel device. The document primarily highlights bench testing results proving compatibility and mechanical performance.
Acceptance Criteria and Device Performance
The document does not explicitly present a table of numerical acceptance criteria alongside reported device performance in the format of a clinical study. Instead, it states that bench testing was performed to determine conformance to performance specifications and requirements.
Table of Acceptance Criteria (Inferred) and Reported Device Performance:
| Acceptance Criteria Category (Inferred from document) | Description / Acceptance Standard (Inferred) | Reported Device Performance |
|---|---|---|
| Mating Characteristics Compatibility | Abutment-implant mating must be compatible. | "all testing showed correct operation of the device as per its intended use, specifically including dimensional compatibility" |
| Mechanical Compression Testing | Must meet specified mechanical strength requirements for compression. | "all testing showed correct operation of the device as per its intended use...mechanical performance testing" |
| Fatigue Testing | Must withstand specified cyclic loading without failure for long-term functional performance. | "all testing showed correct operation of the device as per its intended use...mechanical performance testing" |
| Software Validation (CAD/CAM) | Software must correctly prevent the milling of abutments that do not fulfill Core3D design criteria. | "software validation testing of the software system used to ensure that incorporated design limitations correctly prevent the user from milling abutments that do not fulfill the Core3D design criteria" |
| Compatibility with Implants | Must be compatible with specified dental implants (e.g., Nobel Biocare, Zimmer Tapered Screwvent). | Explicitly states compatibility with these implants. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for the bench tests (e.g., number of abutments tested for mechanical properties).
- Data Provenance: The study was non-clinical bench testing. The document does not specify the country of origin for the data itself, but the submitter is based in Spain. It is retrospective in the sense that the testing was completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by engineering specifications and standards, not by human experts adjudicating clinical outcomes.
- Qualifications of Experts: Not applicable in the context of this type of non-clinical testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable for non-clinical bench testing. The results are typically compared directly against engineering specifications and industry standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
- Effect Size: Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The document does not describe a standalone performance study in the way it might for an AI algorithm. However, standalone bench testing of the physical abutments and an evaluation of the CAD/CAM software (which operates without human intervention in determining design limits once programmed) effectively represent the "algorithm only" performance for the relevant aspects of this device. The software validation aimed to ensure the software's inherent design limitations correctly prevent non-compliant abutment milling.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical and dimensional aspects of the abutments and their mating, the ground truth was based on engineering specifications, industry standards, and perhaps predicate device performance data. For the CAD/CAM software, the ground truth for software validation was the Core3D design specifications and limitations.
8. The Sample Size for the Training Set
- Sample Size for Training Set: This information is not provided and is generally not applicable in a traditional sense for a physical medical device. The CAD/CAM software is likely developed based on engineering rules and algorithms, not "trained" on a data set in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable in the context of this device. The "ground truth" for the software's design rules would have been established by engineering design principles, material properties, and regulatory requirements specific to dental abutments.
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510(k) Premarket Notification
Section 5 - 510(k) Summary
| DATE OF SUBMISSION: | 2013-10-16 |
|---|---|
| SUBMITTER NAME: | Core 3D Protech, S.L. |
| SUBMITTER ADDRESS: | Pol. Ind. Santa Anna, Apartat 2008251 SANTPEDORBARCELONASPAIN |
OCT 2 4 2013
| CONTACT: | Anna Cortina Caixach |
|---|---|
| TELEPHONE: | +34 902 38 38 48 |
| Fax: | +34 93 827 38 73 |
| e-mail: | annacortina@core3dcentres.eu |
| DEVICE TRADE NAME: | Core 3D Abutment System for Digital Prosthetic Solutions |
| COMMON NAME: | Endosseous Dental Implant Abutment |
| CLASSIFICATION NAME: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| PREDICATE DEVICE(S): | NT-Trading (K111935)Biohorizons (K103291) Laser Lok for Nobel BiocareInclusive Dental Solutions (K083192)3M Lava Software (K062493) |
DEVICE DESCRIPTION:
The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations.
The system is composed of the following principal components:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
- Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques
- -Abutment Screws: to fix abutments to the underlying dental implant.
The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system:
- CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer ー
- Scanner: 3Shape D810 model -
- -Milling machine: SAUER HSC-20 DMG.
Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term . functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional
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Image /page/1/Picture/1 description: The image shows the words "core3d" on the top line and "centres" on the bottom line. The text is in a bold, sans-serif font and is black against a white background. The text appears to be slightly distressed, with some areas of the letters appearing faded or worn.
Section 5 - 510(k) Summary
performance are established.
The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm. The available range of diameters and connection types are summarized below:
| Connection Type | Range of diameters | |
|---|---|---|
| Abutment Bases | External Hex | 3.5, 4.1, 5.1 mm (connection) |
| Internal Hex | 3.4, 4.5, 5.7 mm (connection) | |
| Abutment Blanks | External Hex | 3.5, 4.1, 5.1 mm (connection)8 - 12 mm (cylinder) |
| Internal Hex | 3.5, 4.5, 5.7 mm (connection)8 - 12 mm (cylinder) |
INTENDED USE:
As established in the Indications for Use Statement:
The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
- -Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques:
- Abutment Screws to permanently fix the abutments to the underlying implant.
Core 3D abutments are intended for use to support sincle-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
Core 3D abutments and are compatible for use with the following dental implants:
- Nobel Biocare® Brånemark System™ (K022562, K934825) .
- Zimmer® Tapered Screwvent® (K013227, K061410, K072589)
Abutments are placed into the dental implant to provide support for the prosthetic reconstruction including abutments for cemented restorations to achieve better esthetics. Abutments can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
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510(k) Premarket Notification
Image /page/2/Picture/1 description: The image shows the words "core 3d centres" stacked on top of each other. The word "core" is on the top line, followed by "3d", and then "centres" is on the bottom line. The text is in a bold, sans-serif font and is black in color. The background is white.
Section 5 - 510(k) Summary
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the Core 3D Abutment System is compared with the following previously cleared devices:
- NT-Trading (K111935) -
- Biohorizons Laser-Lok for Nobel Biocare (K103291) -
- -Inclusive Dental Solutions - Inclusive Titanium Abutment Blanks (K083192)
- ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ 3M Lava Software (K062493)
Comparison of the proposed devices with the predicate devices is summarized in the following table:
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ි ප්රදමාර්තම ප්රධාන අධිකරණය විශ්වාදය පිහිටා ඇතුළු ප්රධාන බවට පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහි
510(k) Premarket Notificatio
Section 5 – 510(k) Summary
| Summary of comparison with predicate devices | Proposed Device | K111935 NT-Trading | Predicate DevicesK103291 Biohorizons Laser-Lok for Nobel Biocare | K083192 Inclusive Dental Solutions Inclusive Titanium Abutment Blanks | K062493 Lava Software |
|---|---|---|---|---|---|
| Classification /PROCODE | 872.3630 / NHA | 872.3630 / NHA | 872.3630 / NHA | 872.3630 / NHA | 872.3630 / NHA / EIH |
| Intended Use | The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations.The abutments include Titanium Bases to be attached to the underlying implant and upon which a final dental restoration is placed, Titanium Abutment Blanks to be further processed by the dental lab to produce patient-specific abutments and Abutment Screws to permanently fix the abutments to the underlying implant. Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations. | Ti-Base Abutments: The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic restoration.The Ti-Base abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple-tooth prosthesis in the mandible or maxilla. The prosthesis can be cement-retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | Biohorizons Laser-Lok Abutments for Nobel Biocare are intended for use with dental implants as a support for single or multiple unit prostheses in the maxilla or mandible of partially or fully edentulous patients. The abutments are compatible for use with Nobel Biocare™ Nobel Replace™ Straight Groovy™, Nobel Replace™ Tapered Groovy™, NobelSpeedy™ Replace™, Replace™ Select Tapered and Replace™ Select Straight implants with 3.5mm(NP), 4.3mm(RP) and 5.0mm(WP) platform diameter internal tri- | The device is indicated for use by dental technicians in the construction of custom-made dental restorations that are supported by endosseous dental implants.The Inclusive Titanium Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement-retained or screw-retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges.The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system.The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet. |
| Core 3D abutments are compatible for use with the following dental implants:• Nobel Biocare Brånemark System (K022562, K934825)• Nobel Biocare• Nobel Replace (K073132, K062566) | The Ti-Base abutments are Indicated for use with the following implant systems:• Nobel Nobel Biocare® Replace Select®• Nobel Biocare® NobelActive™• Biomet 3i® Osseotite®• Biomet 3i® Osseotite® Certain®• Nobel Biocare® | channel connections. The abutment screw is intended to secure the abutment to the endosseous implant.Biohorizons Laser-Lok Titanium Base Abutments | Inclusive Titanium Abutment Blanks for Nobel Biocare are compatible with NobelActive Internal NP and RP implants. Inclusive Titanium Abutment Blanks for Institut Straumann are |
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Image /page/4/Picture/0 description: The image shows the word "Centres" in bold, black font, oriented vertically. To the left of "Centres" is the word "Core 3d", also oriented vertically. The font of "Core 3d" is a thin, outlined font.
510(k) Premarket Notificatio
Section 5 - 510(k) Summary
| Summary ofcomparison withpredicate devices | Proposed DeviceCore 3D Abutment System | K111935 NT-Trading | Predicate DevicesK103291 BiohorizonsLaser-Lok for NobelBiocare | K083192 Inclusive DentalSolutions Inclusive TitaniumAbutment Blanks | K062493 Lava Software |
|---|---|---|---|---|---|
| NobelNobelActive (K071370) Straumann SLActiveImplants (K053088) Straumann P.0004Implants (K062129) Biomet 3i Osseotite(K063286) Biomet 3i Certain(K063341) Astra Tech OsseoSpeed(K120414) Zimmer Tapered Screwvent(K061410, K072589) | Branemark® Straumann® synOcta® Straumann® Bone Level® Zimmer® Tapered Screw-vent® Astra Tech Osseospeed® Dentsply-Friadent® Frialit® 2-CONnect Abutments: 2-CONnect abutment isindicated for use to providesupport for prostheticrestorations such as bars andbridges. The 2-CONnectabutments can be used inmultiple tooth restorations.The 2-CONnect abutment canbe used together withcemented bridges and barconstructions for functionaland aestheticalreconstruction. The 2-CONnect abutments areindicated for use with thefollowing implant systems:• Nobel Biocare® ReplaceSelect®• Straumann® synOcta®• Straumann Bone Level® | for Nobel are intended tobe used as straightabutments. | compatible with StraumannBone Level implants in theNC and RC platform sizes.Inclusive TitaniumAbutment Blanks for theNobel Biocare BranemarkSystem are compatible withthe Branemark RP sizeimplant.Abutments with angulationsgreater than 20 degrees onimplants less than 4mm indiameter are not indicatedfor the posterior regionbecause of strengthlimitations of the implant. | ||
| Materials-Ti Bases, Screws:Abutment Blanks | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Titanium Alloy |
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Image /page/5/Picture/0 description: The image shows the word "centres" in bold, black, vertical text. To the left of the word "centres" is the number "3d" in a smaller, lighter font. The number "3d" is also oriented vertically.
510(k) Premarket Notificatio
Section 5 – 510(k) Summary
| (062493 Lava Softwar | ie software provides fo | 3D modeling for custom | orms and features of the | superstructure, | e software provides fo | 3D modeling for custom 'orms and features of the | superstructure | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| K083192 Inclusive Dental | butment Blanks | crew-retained to the | mplant. The prosthesis ca | abutment. | ||||||||
| Predicate Devices (103291 Biohorizons | aser-Lok for Nobe | Biocare | Equivalent mating | latform geometry | ||||||||
| K111935 NT-Tradir | Same diameters / heights mode of action | crew-retained or cemer | retained. | |||||||||
| roposed Device | Core 3D Abutment System | quivalent identical abutment | onnection geometry and type, | cluding screw geometry for dicated compatible implant | systems. | crew-retained to the implant. The | osthesis can be cement-retained | lo the abutmer | ||||
| Summary of | omparison wit | edicate device | Form / Features | liameters, height | onnection type | anti-rotational | eatures | Type of retention |
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Image /page/6/Picture/1 description: The image shows the words "core 3d" on the top line and the word "centres" on the bottom line. The text is in a bold, sans-serif font and is black. The image has a slightly distressed or textured appearance.
Section 5 - 510(k) Summary
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as an endosseous dental implant abutment and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Bench testing performed in foreseeable operating conditions included determination of the compatibility of the abutment - implant mating characteristics as well as mechanical compression and fatigue testing - all testing showed correct operation of the device as per its intended use, specifically including dimensional compatibility and mechanical performance testing.
Also, testing included software validation testing of the software system used to ensure that incorporated design limitations correctly prevent the user from milling abutments that do not fulfill the Core3D design criteria.
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device. Clinical data are not submitted.
CONCLUSIONS:
We believe the intended use, the indications for use and performance of the Core3D abutment system for digital prosthetic solutions are the intended use, indications for use and performance of the predicate devices. We also believe that the Core3D devices do not suppose any new or increased risk compared with the predicate devices. Based on the information included in this submission, we conclude that the proposed device is substantially equivalent to the legally marketed predicate devices.
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2013
Core 3D Protech, S.L. Ms. Anna Cortina Caixach Pol. Ind. Santa Anna, Apartat 20 08251 Santpedor Barcelona Spain
Re: K122295
Trade/Device Name: CORE 3D Abutment System for Digital Prosthetic Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: October 16, 2013 Received: October 21, 2013
Dear Ms. Caixach:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Caixach
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
MarySBunner-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification
Image /page/9/Picture/1 description: The image shows the words "core 3d centres" stacked on top of each other. The word "core" is on the top line, followed by "3d" on the same line. The word "centres" is on the second line. The text is in a bold, sans-serif font.
Section 4 - Indications for Use Statement
. PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
(as required by ODE for all 510(k) received after Jan. 1, 1996)
510(k) Number: K122295 Device Name: CORE 3D Abutment System for Digital Prosthetic Solutions Indications for Use:
.
The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:
- Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed . superstructure may be fitted to complete a two-piece dental abulment;
- . Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
- Abutment Screws to permanently fix the abutments to the underlying Implant. .
Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
Core 3D abutments and are compatible for use with the following dental implants:
- Nobel Biocare Branemark System (K022562, K934825) ●
- Zimmer Tapered Screwvent (K013227, K061410, K072589) .
(Do not write below this line. Continue on another page if needed) Concurrence of CDRH. Office of Device Evaluation (ODE)
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Prescription Use / (21 CFR 801 Subpari D)
OR
Over-The-Counter Use (21 CFR 80) Subpart C)
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)