(450 days)
No
The summary describes a dental abutment system designed using CAD/CAM techniques, which are traditional digital design and manufacturing methods, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
Yes.
The device is a dental abutment system used to support dental prosthetic restorations, which is a form of treatment for anatomical defects.
No
This device is a dental abutment system used to provide support for dental prosthetic restorations, not to diagnose a medical condition.
No
The device description clearly states the system is composed of physical components: Titanium Bases, Titanium Abutment Blanks, and Abutment Screws. While CAD/CAM software is used in the design process, the device itself is a physical dental abutment system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that the CORE 3D abutment system consists of dental abutments, titanium bases, titanium abutment blanks, and abutment screws. These are physical components intended to be placed into a dental implant within the patient's mouth to support dental prosthetics.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or to provide diagnostic information about a patient's health condition. The device's function is purely mechanical and structural within the oral cavity.
The device is a medical device, specifically a dental implant abutment system, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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) .
Product codes
NHA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental technicians (implied user of the predicate device for construction of custom-made dental restorations)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to determine conformance to performance specifications and requirements, taking into account the intended use as an endosseous dental implant abutment and following FDA guidance. This included determination of 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. Software validation testing of the software system used was also performed to ensure that incorporated design limitations correctly prevent the user from milling abutments that do not fulfill the Core3D design criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NT-Trading (K111935), Biohorizons (K103291), Inclusive Dental Solutions (K083192), 3M Lava Software (K062493)
Reference Device(s)
Nobel Biocare® Brånemark System™ (K022562, K934825), Zimmer® Tapered Screwvent® (K013227, K061410, K072589), Nobel Replace (K073132, K062566), NobelActive (K071370), Straumann SLActive Implants (K053088), Straumann P.0004 Implants (K062129), Biomet 3i Osseotite (K063286), Biomet 3i Certain (K063341), Astra Tech OsseoSpeed (K120414)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
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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 20 |
| 08251 SANTPEDOR | |
| BARCELONA | |
| SPAIN |
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 Biocare | |
| Inclusive 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
1
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.
2
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:
3
ි 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 Devices
K103291 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 | |
4
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 of
comparison with
predicate devices | Proposed Device
Core 3D Abutment System | K111935 NT-Trading | Predicate Devices
K103291 Biohorizons
Laser-Lok for Nobel
Biocare | K083192 Inclusive Dental
Solutions Inclusive Titanium
Abutment Blanks | K062493 Lava Software |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | Nobel
NobelActive (K071370) Straumann SLActive
Implants (K053088) Straumann P.0004
Implants (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 is
indicated for use to provide
support for prosthetic
restorations such as bars and
bridges. The 2-CONnect
abutments can be used in
multiple tooth restorations.
The 2-CONnect abutment can
be used together with
cemented bridges and bar
constructions for functional
and aesthetical
reconstruction. The 2-
CONnect abutments are
indicated for use with the
following implant systems:
• Nobel Biocare® Replace
Select®
• Straumann® synOcta®
• Straumann Bone Level® | for Nobel are intended to
be used as straight
abutments. | compatible with Straumann
Bone Level implants in the
NC and RC platform sizes.
Inclusive Titanium
Abutment Blanks for the
Nobel Biocare Branemark
System are compatible with
the Branemark RP size
implant.
Abutments with angulations
greater than 20 degrees on
implants less than 4mm in
diameter are not indicated
for the posterior region
because of strength
limitations of the implant. | |
| Materials-
Ti Bases, Screws:
Abutment Blanks | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Titanium Alloy | |
5
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 |
6
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.
7
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.
8
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
9
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)