(163 days)
No
The summary describes a physical dental abutment and its compatibility with existing CAD/CAM software and milling units, with no mention of AI or ML capabilities.
No.
This device is an component used to support dental prosthetic restorations and is not intended to treat or cure a disease or condition itself.
No.
The device is a titanium component that provides support for custom prosthetic restorations, such as copings or crowns, and is used in conjunction with dental implants. Its function is structural and restorative, not diagnostic.
No
The device is a physical titanium component intended for surgical implantation and support of dental prosthetics. While it is used in conjunction with software for design and milling, the device itself is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a titanium component placed over dental implants to support prosthetic restorations. This is a mechanical and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the material, dimensions, and features of a physical implant component. It does not describe any reagents, assays, or methods for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or test kits
The device is a dental implant component used in a surgical and restorative procedure.
N/A
Intended Use / Indications for Use
The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Titanium Base for CEREC consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.
The Titanium Base for CEREC abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications and are provided in a 4.65 mm prosthetic platform diameter and seven gingival heights (0.8, 1.5, 2.5, 3.5, 4.5, 5.5 and 6.5 mm), all having a 4.7 mm prosthetic height. They also feature:
- cylindrical shape
- hexagonal indexing at the apical end of the Morse taper connection
- indexing guide in the cementable portion for coping fitting
The CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
The Titanium Base for CEREC is provided sterile by Ethylene Oxide and steam sterilization is recommended after the cementation of the customized superstructure on the Titanium Base for CEREC.
The Titanium Base for CEREC is compatible with the following devices:
Dental implants
All Neodent dental implants having Morse taper implant-to-abutment interface (CM line) cleared under K101945, K123022, K133592, K150182 and K150199.
Raw material blanks
- InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664;
- IPS e.max CAD Abutments Solutions (LiSi₂) by Ivoclar Vivadent AG, L size blanks, cleared under K132209.
Software
Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.
No change has been made in the software, its settings or configuration, as well as any modification in the workflow. Sirona inLab software (version 3.65) or Sirona CEREC® Software (version 4.2) are to be used to design the prosthesis structure according to the previous prosthetic planning. Therefore, the customers are required to use the device models (3D models) and the workflow defined and validated by Sirona through K111421, according to the Instruction for Use of Titanium Base for CEREC
Instruments
- Neodent screwdrivers (class I - exempt devices)
- Sirona scanbodies (class I exempt devices)
Note: The raw material blanks, the scanbodies and the software are not subject of this submission and are not supplied by Neodent. They are identical to the compatible materials used for predicate devices K151324.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility testing
The subject device Titanium Base for CEREC abutment is made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). This material is commonly used for endosseous dental implant abutments and is the same material used for Neodent Implant System components previously cleared in K150367. Therefore, no new biocompatibility testing has been performed.
Mechanical testing
The strength of the system is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. The Neodent Titanium Base for CEREC does not present a new worst case when compared to the reference device Neodent Titanium Base cleared under K153624. So, no new fatigue tests have been performed, and the same tests presented in K153624 were used to demonstrate the substantial equivalence.
Software Verification and Validation Testing
The recommended software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator. Therefore, the subject Titanium Base for CEREC was verified and validated with respect to its functionality and design using the Sirona validated workflow. The recommended CAD/CAM System is the same used for the primary predicate device and the validation performed was based on the validation presented by the manufacturer of the primary predicate device.
Sterilization validation
The subject Titanium Base for CEREC abutments are provided sterilized by exposure to ethylene oxide (EO). Sterilization has been validated according to ISO 11135 - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices using Annex B - Conservative determination of lethal rate of the sterilization process – Overkill approach.
Following fabrication of the superstructure for the Titanium Base, the assembled (cemented) final abutment must be sterilized before use by moist heat (steam). The recommended sterilization has been validated according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO/TR 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1.
Both methods achieve a Sterility Assurance Level (SAL) of 10-6.
Clinical data
No clinical data has been submitted, referenced, or relied upon to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.)
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
JJGC Indústria e Comércio de Materiais Dentários SA % Jennifer Jackson Senior Manager, Regulatory Affairs & Quality Management Straumann USA, LLC 60-100 Minuteman Road Andover, Massachusetts 01810
Re: K160964
Trade/Device Name: Neodent Implant System - Titanium Bases For Cerec Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 11, 2016 Received: August 18, 2016
Dear Jennifer Jackson:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Neodent Implant System - Titanium Bases for CEREC
Indications for Use (Describe)
The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Submitter | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315
Owner/Operator No.: 9005052 | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | on behalf of: | | | |
| | JJGC Indústria e Comércio de Materiais Dentários SA
Av. Juscelino Kubitschek de Olivera, 3291
Curtiba, Parana, BRAZIL 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 | | | |
| Contact Person | Jennifer Jackson, MS
Head of Quality and Regulatory, Straumann USA
Telephone (978) 747-2509 | | | |
| Date Prepared | 15/Sep/2016 | | | |
| Prepared by | Ana Carolina Martins Vianna
Regulatory Affairs Analyst, JJGC Indústria e Comércio de Materiais
Dentários SA
avianna@neodent.com.br | | | |
| Product Code | NHA (21 CFR 872.3630) | | | |
| Device Class | II (21 CFR 872.3630) | | | |
| Classification Panel | Dental | | | |
| Classification Name | Endosseous dental implant abutment (21 CFR 872.3630) | | | |
| Common Name | Endosseous dental implant abutment | | | |
| Proprietary name | Neodent Implant System – Titanium Bases for CEREC | | | |
| Primary Predicate | K151324 - Straumann® Variobase™ for CEREC Abutments, Institut
Straumann AG | | | |
| Reference Predicates | K153624 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários SA
K111421 - Sirona Dental CAD/CAM System | | | |
Device Description 5.1
4
The Titanium Base for CEREC consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.
The Titanium Base for CEREC abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications and are provided in a 4.65 mm prosthetic platform diameter and seven gingival heights (0.8, 1.5, 2.5, 3.5, 4.5, 5.5 and 6.5 mm), all having a 4.7 mm prosthetic height. They also feature:
- cylindrical shape
- hexagonal indexing at the apical end of the Morse taper connection
- indexing guide in the cementable portion for coping fitting
Image /page/4/Picture/7 description: The image shows a dental implant abutment. The abutment is made of metal and has a cylindrical shape. The top of the abutment has a hole in it, and the bottom of the abutment has a screw thread. The abutment is used to connect a dental crown to a dental implant.
Figure 1: Image of a Titanium Base for CEREC abutment
The CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
The Titanium Base for CEREC is provided sterile by Ethylene Oxide and steam sterilization is recommended after the cementation of the customized superstructure on the Titanium Base for CEREC.
The Titanium Base for CEREC is compatible with the following devices:
Dental implants
All Neodent dental implants having Morse taper implant-to-abutment interface (CM line) cleared under K101945, K123022, K133592, K150182 and K150199.
Raw material blanks
- -InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664;
- -IPS e.max CAD Abutments Solutions (LiSi₂) by Ivoclar Vivadent AG, L size blanks, cleared under K132209.
Software
Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.
5
No change has been made in the software, its settings or configuration, as well as any modification in the workflow. Sirona inLab software (version 3.65) or Sirona CEREC® Software (version 4.2) are to be used to design the prosthesis structure according to the previous prosthetic planning. Therefore, the customers are required to use the device models (3D models) and the workflow defined and validated by Sirona through K111421, according to the Instruction for Use of Titanium Base for CEREC
Instruments
- -Neodent screwdrivers (class I - exempt devices)
- Sirona scanbodies (class I exempt devices) ।
Note: The raw material blanks, the scanbodies and the software are not subject of this submission and are not supplied by Neodent. They are identical to the compatible materials used for predicate devices K151324.
5.2 Indications for Use
The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
5.3 Technological Characteristics
Both the subject and the reference devices have the same indication of providing support for prostheses. All devices are pre-manufactured (stock) abutments made of titanium alloy design to be used as a base when fabricating a CAD/CAM customized superstructure and are compatible with the same CAD/CAM System and blocks of raw material. A clinician or dental laboratory equipped with the Sirona Dental CAD/CAM System will design and mill the customized superstructure, which composes the final medical device after the bonding to the Titanium Base for CEREC.
The subject devices differ from the primary predicate devices cleared under K151324 only in the portion of implant connection, which is specific for each manufacturer. The cementable portion is identical and compatible with the Sirona Dental CAD/CAM System and the blocks of raw material.
In the end of this Section a comparison between the features of subject device and its predicate devices is shown in a tabular format. The assessment of the differences is also included.
5.4 Performance data
6
The following performance data supports the substantial equivalence determination: Biocompatibility testing
The subject device Titanium Base for CEREC abutment is made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). This material is commonly used for endosseous dental implant abutments and is the same material used for Neodent Implant System components previously cleared in K150367. Therefore, no new biocompatibility testing has been performed.
Mechanical testing
The strength of the system is demonstrated through fatigue testing performed according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. The Neodent Titanium Base for CEREC does not present a new worst case when compared to the reference device Neodent Titanium Base cleared under K153624. So, no new fatigue tests have been performed, and the same tests presented in K153624 were used to demonstrate the substantial equivalence.
Software Verification and Validation Testing
The recommended software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator. Therefore, the subject Titanium Base for CEREC was verified and validated with respect to its functionality and design using the Sirona validated workflow. The recommended CAD/CAM System is the same used for the primary predicate device and the validation performed was based on the validation presented by the manufacturer of the primary predicate device.
Note: Neodent makes no changes to the software, its settings or configuration, as well as no modification in the workflow defined and validated by Sirona per K111421. The Sirona software is recommended because of the compatibility of its existing 3D models with the subject devices.
Sterilization validation
The subject Titanium Base for CEREC abutments are provided sterilized by exposure to ethylene oxide (EO). Sterilization has been validated according to ISO 11135 - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices using Annex B - Conservative determination of lethal rate of the sterilization process – Overkill approach.
Following fabrication of the superstructure for the Titanium Base, the assembled (cemented) final abutment must be sterilized before use by moist heat (steam). The recommended sterilization has been validated according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO/TR 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1.
JJGC Indústria e Comércio de Materiais Dentários S.A.
7
Both methods achieve a Sterility Assurance Level (SAL) of 10 °.
Clinical data
No clinical data has been submitted, referenced, or relied upon to demonstrate substantial equivalence.
8
Table 2: Comparison between the subject and predicate devices.
| SUBJECT DEVICE | PRIMARY DEVICES | REFERENCE PREDICATE | |||
|---|---|---|---|---|---|
| Neodent Implant System - | |||||
| Titanium Base for CEREC® | Straumann® Variobase® for | ||||
| CEREC® (K151324) | Neodent Implant System | ||||
| (K153624) | Sirona Dental CAD/CAM System | ||||
| (K111421) | EQUIVALENCE DISCUSSION | ||||
| Indications for | |||||
| Use | The Titanium Base for CEREC | ||||
| is a titanium component that | |||||
| is placed over Neodent | |||||
| Implants to provide support | |||||
| for custom prosthetic | |||||
| restorations, such as copings | |||||
| or crowns. It is indicated for | |||||
| single-tooth screw-retained | |||||
| restorations. | |||||
| All digitally designed copings | |||||
| and/or crowns for use with | |||||
| the Neodent Titanium Base | |||||
| for CEREC are to be designed | |||||
| using Sirona inLab software | |||||
| or Sirona CEREC Software and | |||||
| manufactured using a Sirona | |||||
| CEREC or inLab MC X or MC XL | |||||
| milling unit. | The Straumann® Variobase® | ||||
| for CEREC® are titanium | |||||
| alloy abutments placed onto | |||||
| Straumann dental implants | |||||
| to provide support for | |||||
| customized prosthetic | |||||
| restorations. Straumann® | |||||
| Variobase® for CEREC® | |||||
| abutments are indicated for | |||||
| screw-retained single tooth | |||||
| or cement-retained single | |||||
| tooth and bridge | |||||
| restorations. | |||||
| All digitally designed | |||||
| copings and/or crowns for | |||||
| use with the Straumann® | |||||
| Variobase® for CEREC® | |||||
| abutments are to be | |||||
| designed using Sirona inLab | |||||
| software | |||||
| (Version 3.65) or Sirona | |||||
| CEREC Software (Version | |||||
| 4.2) and | |||||
| manufactured using a | |||||
| Sirona CEREC or inLab MC X | |||||
| or MC XL milling unit. | Titanium Base Abutment is a | ||||
| titanium base placed onto | |||||
| Neodent dental implants to | |||||
| provide support for | |||||
| customized prosthetic | |||||
| restorations. It is used with a | |||||
| coping and crown, or crown | |||||
| alone, and is indicated for | |||||
| cement-retained single or | |||||
| multi-unit restorations, or | |||||
| screw-retained single | |||||
| restorations. | |||||
| All digitally designed copings | |||||
| and/or crowns for use with | |||||
| the Neodent Titanium Base | |||||
| Abutment System are | |||||
| intended to be sent to | |||||
| Straumann for manufacture at | |||||
| a validated milling center. | The Sirona Dental CAD/CAM System is | ||||
| intended for use in partially or fully | |||||
| edentulous mandibles and maxillae in | |||||
| support of single or multiple-unit | |||||
| cement retained restoration. The | |||||
| system consists of three major parts: | |||||
| TiBase, InCoris mesostructure, and | |||||
| CAD/CAM software. Specifically, the | |||||
| InCoris mesostructure and TiBase | |||||
| components make up a two-piece | |||||
| abutment which is used in conjunction | |||||
| with endosseous dental implants to | |||||
| restore the function and aesthetic in | |||||
| the oral cavity. The InCoris | |||||
| mesostructure may also be used in | |||||
| conjunction with the Camlog Titanium | |||||
| base CAD/CAM (types K2244.xxxx) | |||||
| (K083496) in the Camlog Implant | |||||
| System. The CAD/CAM software is | |||||
| intended to design and fabricate the | |||||
| InCoris mesostructure. The InCoris | |||||
| mesostructure and TiBase two-piece | |||||
| abutment is compatible with the | |||||
| following implant systems: | |||||
| Nobel Biocare Replace (K020646) | |||||
| Nobel Biocare Branemark (K022562) | |||||
| Friadent Xive (K013867) | |||||
| Biomet 3i Osseotite (KK980549) | |||||
| Astra Tech Osseospeed (K091239) | |||||
| Zimmer Tapered Screw-Vent (K061410) | |||||
| Straumann SynOcta (K061176) | |||||
| Biomet 3i Certain (K014235) | |||||
| Nobel Biocare Active (K071370) | Equivalent | ||||
| The basic indication of | |||||
| providing support for | |||||
| prostheses is identical. All | |||||
| devices are CAD/CAM | |||||
| abutment design to be used | |||||
| as a base when fabricating a | |||||
| customized superstructure. | |||||
| The subject devices are | |||||
| compatible with the same | |||||
| CAD/CAM System as the | |||||
| primary predicate device. | |||||
| SUBJECT DEVICE | PRIMARY DEVICES | REFERENCE PREDICATE | |||
| Neodent Implant System - Titanium Base for CEREC® | Straumann® Variobase® for CEREC® (K151324) | Neodent Implant System (K153624) | Sirona Dental CAD/CAM System (K111421) | EQUIVALENCE DISCUSSION | |
| Abutment Diameter(s) | 4.65 mm | 4.5 to 7.0 mm | 3.5 and 4.5 mm | Unknown | Equivalent |
| Subject devices diameter is within the range of diameters for the primary predicate devices and does not represent a worst case in terms of performance. | |||||
| Implant-to-Abutment Connection | Morse taper (CM) interface | RN (Regular Neck), | |||
| WN (Wide Neck), | |||||
| NC (Narrow CrossFit), and | |||||
| RC (Regular CrossFit) | Morse taper (CM) interface | Unknown | Equivalent | ||
| The implant-to-abutment interfaces of Neodent and Straumann devices are not interchangeable but it is identical to the reference predicates of K153624. | |||||
| Compatibility | Morse taper (CM) implant lines of Neodent Implant System. | Straumann implant lines, as indicated by the implant-to-abutment interfaces. | Morse taper (CM) implant lines of Neodent Implant System. | Unknown | Equivalent |
| The implant-to-abutment interfaces of Neodent and Straumann devices are not interchangeable but it is identical to the reference predicates of K153624. | |||||
| Mode of attachment | Screw-retained | Screw-retained or cement retained | Screw-retained or cement retained | Screw-retained | Equivalent |
| Subject device mode of attachment is more restrictive and is within the scope of the primary predicate device's mode of attachment. | |||||
| SUBJECT DEVICE | PRIMARY DEVICES | REFERENCE PREDICATE | |||
| Neodent Implant System - | |||||
| Titanium Base for CEREC® | Straumann® Variobase® for | ||||
| CEREC® (K151324) | Neodent Implant System | ||||
| (K153624) | Sirona Dental CAD/CAM System | ||||
| (K111421) | EQUIVALENCE DISCUSSION | ||||
| Restoration | |||||
| Angulation(s) | Up to 20° | Up to 20° | Up to 30° | Up to 20° | Equivalent |
| The restoration angulation is | |||||
| identical among the devices | |||||
| that use Sirona Dental | |||||
| CAD/CAM System and only | |||||
| differs for the reference | |||||
| device K153624 that is | |||||
| compatible with other | |||||
| software. | |||||
| Abutment | |||||
| Height(s) | 4.7 mm | 4.7 mm | 4.0 mm | Unknown | Equivalent |
| Subject device height is | |||||
| identical to that of the | |||||
| primary predicate device; | |||||
| differs from the reference | |||||
| device, which uses other | |||||
| CADCAM Systems. | |||||
| Material of | |||||
| abutment | Titanium-aluminum- | ||||
| vanadium alloy Ti-6Al-4V | Titanium-Aluminum- | ||||
| Niobium alloy (Ti-6Al-7Nb) | Titanium-aluminum- | ||||
| vanadium alloy Ti-6Al-4V | Titanium-aluminum- | ||||
| vanadium alloy Ti-6Al-4V | Equivalent | ||||
| The subject and reference | |||||
| devices are made of the | |||||
| same titanium alloy; the | |||||
| titanium alloy of the primary | |||||
| predicate device differs, but | |||||
| the strength of the materials | |||||
| is demonstrated via dynamic | |||||
| fatigue testing. Also, all | |||||
| materials are shown to be | |||||
| biocompatible. | |||||
| SUBJECT DEVICE | PRIMARY DEVICES | REFERENCE PREDICATE | |||
| Neodent Implant System - | |||||
| Titanium Base for CEREC® | Straumann® Variobase® for | ||||
| CEREC® (K151324) | Neodent Implant System | ||||
| (K153624) | Sirona Dental CAD/CAM System | ||||
| (K111421) | EQUIVALENCE DISCUSSION | ||||
| Material of | |||||
| superstructure | Zirconia | ||||
| IPS e-max CAD | Zirconia | ||||
| IPS e-max CAD | |||||
| PMMA | Zirconia | ||||
| IPS e-max CAD | |||||
| Co-Cr | Zirconia | Equivalent | |||
| The range of materials | |||||
| cleared for use with the | |||||
| primary predicate and | |||||
| reference devices is within | |||||
| the scope of materials | |||||
| indicated for the subject | |||||
| devices. | |||||
| Patient-specific | |||||
| design | CAD/CAM manufactured | ||||
| superstructures | CAD/CAM manufactured | ||||
| superstructures | CAD/CAM manufactured | ||||
| superstructures | CAD/CAM manufactured | ||||
| superstructures | Identical | ||||
| Manufacturing | |||||
| work-flow | Sirona Dental CAD/CAM | ||||
| System | Sirona Dental CAD/CAM | ||||
| System | Straumann validated | ||||
| workflow at Straumann | |||||
| Milling Center | Sirona Dental CAD/CAM System | Equivalent | |||
| The subject device | |||||
| manufacturing work-flow is | |||||
| the same of the primary | |||||
| predicate device workflow. | |||||
| Sterility | Delivered sterile by EO | ||||
| exposure. To be sterilized by | |||||
| user after superstructure | |||||
| cementation, before placed in | |||||
| patient mouth. | Delivered non-sterile.; To | ||||
| be sterilized by user after | |||||
| superstructure | |||||
| cementation, before placed | |||||
| in patient mouth. | Delivered sterile by EO | ||||
| exposure. To be sterilized by | |||||
| user after superstructure | |||||
| cementation, before placed in | |||||
| patient mouth. | Delivered non-sterile; to be | ||||
| sterilized by user. | Equivalent | ||||
| Although Neodent and | |||||
| predicate devices are sold to | |||||
| the customers in different | |||||
| sterilization condition, all | |||||
| final abutments must be | |||||
| sterilized by steam before be | |||||
| placed in patient mouth. | |||||
| Sterilization by | |||||
| end user | Moist steam sterilization | Moist steam sterilization | Moist steam sterilization | Moist steam sterilization | Identical |
9
10
11
12
5.5 Conclusions
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.