(82 days)
No
The summary describes a dental implant abutment and its integration into a digital dentistry workflow involving CAD/CAM software and milling. There is no mention of AI or ML being used for design, analysis, or any other function of the device or its associated workflow.
Yes.
The device is a prosthetic component intended to aid in prosthetic rehabilitation, which directly addresses a health condition (missing teeth) for therapeutic purposes.
No
The device is a premanufactured prosthetic component (dental implant abutment) intended for use as an aid in prosthetic rehabilitation, serving as a platform for an in-laboratory CAD/CAM system to create a mesostructure. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is a physical component (titanium base and mesostructure) and the performance studies include mechanical testing and biocompatibility testing, which are relevant to hardware. While it integrates with software, the device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for prosthetic rehabilitation by connecting to dental implants. This is a direct interaction with the patient's body for a restorative purpose.
- Device Description: It's described as a dental implant abutment, a component used in dental prosthetics.
- Function: Its function is to serve as a platform for a CAD/CAM designed mesostructure, facilitating the creation of a dental restoration.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Universal Base Conical Connection is a premanufactured prosthetic component directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Universal Base Conical Connection consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device Description
The Universal Base Conical Connection is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing conical connections.
The Universal Base Conical Connection features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.
The Universal Base Conical Connection is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Conical Connection is made of titanium vanadium alloy.
The digital workflow requires the use of the following equipment:
- Scanner: 3Shape intra oral scanner Trios (3Shape A/S)
- Design Software: 3Shape Abutment Designer Software (3Shape A/S) K151455
- Restorative Material: VITA ENAMIC Implant Solutions (IS) (Vita Zahnfabrik H. Rauter GmbH Co) K153645
- Milling Unit: CORiTEC, imes-icore milling unit
The following restorative design specifications is required:
Parameter: Angle from axis of the implant, Specification: 20° Max
Parameter: Wall Thickness Circular, Specification: 0.8mm min
Parameter: Wall Thickness Margin, Specification: 0.275mm min
Parameter: Post Height, Specification: 5.2mm min
Parameter: Maximum Length, width and Height, Specification: EM-14 blank 12x14x18mm EM-10 blank 8x10x15mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan files from Intra-Oral Scanners
Anatomical Site
endosseous dental implants
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)
Mechanical Testing: Worst case dynamic fatigue testing per ISO 14801:"Dentistry - Implants - Dynamic loading test for endosseous dental implants" was performed and demonstrated compliance with the minimum required fatigue properties of the Universal Base Abutment conical connection with a bonded VITA ENAMIC IS mesostructure.
Biocompatibility Testing: The biocompatibility evaluation for the Universal Base Conical Connection was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Chemical Characterization. The Universal Base Conical Connection is categorized as a long term, implant device with tissue bone contact according to ISO 10993-1.
Software Verification and Validation: Validation was completed on the Universal Base Conical Connection with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer TM Software (K151455). Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
Sterilization Validation: The proposed devices are provided non-sterile and intended to be steam sterilized by the end user. Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1. and ISO 17665-2.
Packaging: The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
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.)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 30, 2020
Nobel Biocare AG Bernice Jim Regulatory Affairs Manager Balz Zimmermann-Strasse 7 8302 Kloten, Zurich SWITZERLAND
Re: K200040
Trade/Device Name: Universal Base Conical Connection (CC) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA PNP Dated: December 18, 2019 Received: January 13, 2020
Dear Bernice Jim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200040
Device Name Universal Base Conical Connection (CC)
Indications for Use (Describe)
The Universal Base Conical Connection is a premanufactured prosthetic component directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Universal Base Conical Connection consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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A.4. 510(K) Summary
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by: Nobel Biocare Services AG Balz Zimmermann-Strasse 7 8302 Kloten, Switzerland 92887
Contact Person: Bernice Jim, Ph.D., Regulatory Affairs Manager E-Mail: bernice.jim@nobelbiocare.com Phone: (+41) 79 855 00 73 Fax: (+41) 43 211 42 42
Date Prepared: March 30, 2020
II. DEVICE
Name of Device: Universal Base Conical Connection (CC) Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant (21 CFR 872.3630) Regulatory Class: II Product Code: NHA Secondary Code: PNP
III. PREDICATE DEVICE Primary Predicate K180899, Nobel Biocare Universal Base Abutment
IV. REFERENCE DEVICE
Reference Device K151455, 3Shape A/S - 3Shape Abutment Designer Software K153645, Vita Zahnfabrik H. Rauter GmbH Co - Vita Enamic® Implant Solutions (IS) K130436, Multilink Hybrid Abutment Cement - Ivoclar Vivadent, Inc.
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v. DEVICE DESCRIPTION
The Universal Base Conical Connection is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing conical connections.
The Universal Base Conical Connection features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.
The Universal Base Conical Connection is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Conical Connection is made of titanium vanadium alloy.
The digital workflow requires the use of the following equipment: - Scanner: 3Shape intra oral scanner Trios (3Shape A/S) - Design Software: 3Shape Abutment Designer Software (3Shape A/S) K151455 - Restorative Material: VITA ENAMIC Implant Solutions (IS) (Vita Zahnfabrik H. Rauter GmbH Co) K153645 - Milling Unit: CORiTEC, imes-icore milling unit
| Parameter | Specification |
|---|---|
| Angle from axis of the implant | 20° Max |
| Wall Thickness Circular | 0.8mm min |
| Wall Thickness Margin | 0.275mm min |
| Post Height | 5.2mm min |
| Maximum Length, width and Height | EM-14 blank 12x14x18mm EM-10 blank |
| 8x10x15mm |
The following restorative design specifications is required:
VI.INDICATIONS FOR USE
The Universal Base Conical Connection is a premanufactured prosthetic component directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Universal Base Conical Connection consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
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VII. Comparison of Technological Characteristics
| Technological
| characteristics | Subject Device | Primary Predicate | |
|---|---|---|---|
| Universal Base Conical | |||
| Connection | Universal Base Abutment | ||
| (K180899) | |||
| Design Features | Compatible | ||
| Implant | |||
| Platform | Nobel Biocare | ||
| Internal Conical Connection | |||
| Narrow Platform (NP) | |||
| Regular Platform (RP) | |||
| Wide Platform (WP) | Nobel Biocare | ||
| External Hex | |||
| Narrow Platform (NP) | |||
| Regular Platform (RP) | |||
| Wide Platform (WP) | |||
| Ti-base | |||
| Material | Titanium vanadium alloy | ||
| (ASTM F136) | Titanium vanadium alloy | ||
| (ASTM F136) | |||
| Mesostructure/ | |||
| Crown Material | VITA ENAMIC Implant | ||
| Solutions (IS)(K153645) | VITA ENAMIC Implant | ||
| Solutions (IS) (K153645) | |||
| Abutment | |||
| Design | 2 piece - VITA ENAMIC | ||
| IS(K153645) bonded to | |||
| Universal Base Abutment | |||
| mounted on to the implant and | |||
| fixed with a screw | 2 piece - VITA ENAMIC IS | ||
| (K153645) bonded to Universal | |||
| Base Abutment mounted on to | |||
| the implant and fixed with a | |||
| screw | |||
| Abutment | |||
| Fixation | Screwed | Screwed | |
| Maximum | |||
| Abutment | |||
| Angulation | 20° | 20° | |
| Design | |||
| Workflow | 3Shape intra oral scanner Trios | ||
| (3Shape A/S), 3Shape | |||
| Abutment Designer Software | |||
| (3Shape A/S) - K151455 | 3Shape intra oral scanner Trios | ||
| (3Shape A/S), 3Shape | |||
| Abutment Designer Software | |||
| (3Shape A/S) - K151455 | |||
| Manufacturing | |||
| Workflow | CORITEC milling unit (imes- | ||
| icore) | |||
| Traditional workflow | CORITEC milling unit (imes- | ||
| icore) | |||
| Traditional workflow | |||
| Mechanical | |||
| Testing | Dynamic Fatigue | ||
| Testing per ISO 14801 | Dynamic Fatigue | ||
| Testing per ISO14801 | |||
| Intended Use | The Universal Base Conical | ||
| Connection are attached to | |||
| Nobel Biocare dental implants | |||
| and are intended to support a | |||
| crown. | The Universal Base Abutments | ||
| are attached to Nobel Biocare | |||
| dental implants and are | |||
| intended to support a crown. | |||
| Technological | |||
| characteristics | Subject Device | ||
| Universal Base Conical | |||
| Connection | Primary Predicate | ||
| Universal Base Abutment | |||
| (K180899) | |||
| Indications for Use | The Universal Base Conical | ||
| Connection is premanufactured | |||
| prosthetic components directly | |||
| connected to endosseous | |||
| dental implants and are | |||
| intended for use as an aid in | |||
| prosthetic rehabilitation. The | |||
| Universal Base Abutments | |||
| consist of two major | |||
| parts. Specifically, the titanium | |||
| base and mesostructure | |||
| components make up a two- | |||
| piece abutment. The system | |||
| integrates multiple components | |||
| of the digital dentistry workflow: | |||
| scan files from Intra-Oral | |||
| Scanners, CAD software, CAM | |||
| software, ceramic material, | |||
| milling machine and associated | |||
| tooling and accessories. | The Universal Base Abutments | ||
| are premanufactured prosthetic | |||
| components directly connected | |||
| to endosseous dental implants | |||
| and are intended for use as an | |||
| aid in prosthetic rehabilitation. | |||
| The Universal Base Abutments | |||
| consist of two major | |||
| parts. Specifically, the titanium | |||
| base and mesostructure | |||
| components make up a two- | |||
| piece abutment. The system | |||
| integrates multiple components | |||
| of the digital dentistry workflow: | |||
| scan files from Intra-Oral | |||
| Scanners, CAD software, CAM | |||
| software, ceramic material, | |||
| milling machine and associated | |||
| tooling and accessories. |
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Analysis of Differences Between Subiect Device and Predicate
The Universal Base Conical Connection and predicate device, Universal Base Abutment are both abutment systems intended to fit the Nobel Biocare dental implants. Both systems consist of a titanium abutment component and a mesostructured composed of VITA ENAMIC Implant Solutions (IS) (K153645) material. Furthermore, both systems feature a screwed abutment fixation which allows for a maximum abutment angulation correction of 20 degrees.
Discussion about the differences between the subject device and predicate is provided below.
Design Feature - Compatible Implant Platform
The subject device differs from the predicate device in the compatible implant platform, the subject device is designed to be compatible with the internal connection implants. The predicate device is compatible with the implant connection external hex only. To facilitate the connection with the conical connection implants the lower portion of the universal abutment has been modified and differs from the predicate, these modifications are discussion further below. The post portion of the abutment remains the same as the predicate. All other features of the abutment are the same as the predicate, Universal Base Abutment (K180899).
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Differences:
Connection Shape: The subject device has a cone shape which extends into a hexagon shape at the apex of the abutment. The predicate has a hexagon shape at the apex of the abutment. The shape change facilitates the compatibility with the conical connection implant.
Abutment/Implant connection type: For the conical connection, the abutment is the male, the implant is the female connection, for the predicate, the abutment is the female connection and the implant is the male.
Summary:
The design differences between the subject and predicate device do not raise different questions of safety or effectiveness compared to the predicate. Differences in technology were evaluated through performance testing.
VIII. PERFORMANCE DATA
The following performance testing was submitted in this 510(K) to support substantial equivalence:
Mechanical Testing
Worst case dynamic fatigue testing per ISO 14801:"Dentistry - Implants - Dynamic loading test for endosseous dental implants" was performed and demonstrated compliance with the minimum required fatigue properties of the Universal Base Abutment conical connection with a bonded VITA ENAMIC IS mesostructure.
Biocompatibility Testing
The biocompatibility evaluation for the Universal Base Conical Connection was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Chemical Characterization .
The Universal Base Conical Connection is categorized as a long term, implant device with tissue bone contact according to ISO 10993-1. The Universal Base Conical Connection is made of titanium vanadium alloy (ASTM F136).
Software Verification and Validation
Validation was completed on the Universal Base Conical Connection with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment Designer TM Software (K151455). Software verification and validation testing was conducted to demonstrate that
8
the restrictions prevent design of the mesostructure component outside of design limitations. including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
Sterilization Validation
The proposed devices are provided non-sterile and intended to be steam sterilized by the end user. Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1. and ISO 17665-2.
Packaging
Since the subject device does not represent a new worst case in terms of device packaging and shelf life, data from the predicate was leveraged as follows: The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required.
IX. CONCLUSIONS
The Universal Base Conical Connection was evaluated for substantial equivalence using standard and/or comparative testing. In cases were the Universal Base Conical Connection could be demonstrated as not to represent the worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the Universal Base Conical Connection has been shown to be substantially equivalent to the predicate.