(247 days)
No
The summary describes a mechanical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an abutment system for dental implants used to support prosthetic dental restorations, indicating it directly contributes to the treatment and restoration of a patient's oral health and function, which falls under the definition of a therapeutic device.
No.
The device is described as an abutment system for dental implants used to support fixed prosthetic restorations, not to diagnose a condition.
No
The device description explicitly details physical components made of titanium alloy and PEEK, including abutments, caps, and instruments. The performance studies also focus on physical properties like fatigue and pull-out strength. There is no mention of software as a component or function of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to support fixed prosthetic dental restorations in patients. This is a direct medical intervention on the patient's body.
- Device Description: The description details the physical components of the abutment system, which are designed to be implanted and used within the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a component of a dental prosthesis.
N/A
Intended Use / Indications for Use
The Conometric Abutments are intended to be used in conjunction with the Conometric Final Cap and Ankylos C/X implants, OsseoSpeed EV implants and Xive S implants to support fixed friction retained single crowns, in mandible or maxilla, in a partially or completely edentulous patient. This system is intended for delayed loading. The Conometric Abutment including the abutment screw and the Conometric Final Cap make up the final abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The proposed Conometric Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations. The conometric concept provides conical friction retention for fixed single tooth restorations. The Conometric Abutments are provided together with prosthetic conometric caps, impression laboratory devices, and insertion and fixation instruments.
The abutments are provided with an angulation of 0° and 15° at gingival heights of 1.5, 3.0 and 4.5 mm for Ankylos® Conometric Abutments and with 1.0, 2.0 and 3.0 mm for Xive® and Astra Tech Implant System EV® Conometric Abutments. They are manufactured of Titanium Alloy.
The Conometric Final Caps are to be cemented into the final crown to provide friction retention to the abutment. They are made of gold-shaded titanium and are available in the diameter of 3.3 and 4.5 mm.
The Conometric Temporization Caps provide support of immediate and short term provisional prosthetic restorations on Conometric Abutments up to 6 months. The temporary caps are provided with the diameter 3.3 mm and 4.5 mm and are manufactured of PEEK material. The smaller cap (Ø 3.3 mm) also contains titanium alloy.
The Conometric Healing Caps protect the Conometric Abutment until a crown is placed and serve for the shaping of the gingiva. The Healing Caps are made of PEEK polymer and available with an diameter of 3.3 mm and 4.5 mm. Regarding the outer geometries, the Healing Caps are presented as a wide variant with an maximum outer diameter of 6.0 mm and - for the Healing Cap Ø 3.3 mm - also as a small version with an maximum outer diameter of 4.8 mm.
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 clinicians
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes:
- Fatigue Testing: Dynamic fatigue testing was conducted on the worst case construct of the subject abutment (including the Conometric Final Cap) and predicate devices according to ISO 14801 Dental- implants Dynamic Fatigue Test for Endosseous Dental Implants. The friction based retention of the proposed Conometric Abutments was tested under dynamic load. The defined acceptance criteria were fulfilled.
- Pull-out Test: The removal torque of implants after several removal procedures of the Final Cap from the Conometric Abutment have been measured in synthetic bone and compared with test and literature data regarding insertion torque of the Final Cap onto the abutment, removal torques of standard prosthetic restorations (cemented crown) and the pull-out forces of osseointegrated implants. The results showed that the proposed Conometric Abutment system perform as intended.
- Biocompatibility: Material and manufacturing of the proposed Conometric Abutments are identical to those of the predicate device. Thus, biocompatibility data are referenced to support substantial equivalence. Biocompatibility of the Conometric Final Cap, Conometric Temporization Cap and the Conometric Healing Caps, consisting of same material as the predicate devices, have been proved by testing according to ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of materials.
- Sterilization: Sterilization validation of sterile devices is referenced by equivalence (and supported by technical equivalence rationale) to sterilization validation of existing worst-case challenge validations conducted according to ISO 11137-1 Sterilization of health care products --Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose which conclude that a sterility assurance level (SAL) of 10-6 is achieved under the sterilization process parameters utilized.
- Moist heat validation sterilization parameters of non-sterile components were validated by equivalence to sterilization of existing worst-case challenge validations conducted 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 ISO17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1demonstrating a sterility assurance level (SAL) of 10-6.
- Packaging and materials are the same as used for the predicate devices. Thus, shelf life data are referenced to support substantial equivalence.
No human clinical data was included in this premarket notification to support the substantial equivalence of the subject Conometric Abutments.
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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July 10, 2019
Dentsply Sirona Inc. Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K183079
Trade/Device Name: Conometric Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 12, 2019 Received: June 13, 2019
Dear Karl Nittinger:
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 (QS) 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. Acting Assistant 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
Indications for Use
510(k) Number (if known) K183079
Device Name Conometric Abutments
Indications for Use (Describe)
The Conometric Abutments are intended to be used in conjunction with the Conometric Final Cap and Ankylos C/X implants, OsseoSpeed EV implants and Xive S implants to support fixed friction retained single or maxilla, in a partially or completely edentulous patient. This system is intended for delayed loading. The Conometric Abutment including the abutment screw and the Conometric Final abutment. The abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
| 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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3
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
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SECTION 5. 510(k) SUMMARY for Conometric Abutments
- 1.0 Submitter Information:
Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-487-4424 |
| Fax Number: | 717-849-4343 |
Date Prepared: 9-July-2019
Device Name:
- Proprietary Name: Conometric Abutments • Classification Name: Endosseous dental implant abutment .
- CFR Number: 21 CFR 872.3630
- . • Device Class: II
- Product Code: NHA (Abutment, Implant, Dental, Endosseous)
3.0 Predicate Device:
•
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Ankylos® C/X Dental Implant System | ||
| (Ankylos® Regular Abutments) | K140347 | Dentsply Sirona |
| Reference Device Name | 510(k) | Company Name |
| Osseospeed Plus | K120414 | Dentsply Sirona |
| (former: Astra Tech AB) | ||
| XiVE® S plus Dental Implant System | K073075 | |
| (former: Friadent GmbH) | ||
| Atlantis Abutment for MIS Implant | K172225 | Dentsply Sirona |
4.0 Description of Device:
The proposed Conometric Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations. The conometric concept provides conical friction retention for fixed single tooth restorations. The Conometric Abutments are provided together with prosthetic conometric caps, impression laboratory devices, and insertion and fixation instruments.
The abutments are provided with an angulation of 0° and 15° at gingival heights of 1.5, 3.0 and 4.5 mm for Ankylos® Conometric Abutments and with 1.0, 2.0 and 3.0 mm for Xive® and Astra Tech Implant System EV® Conometric Abutments. They are manufactured of Titanium Alloy.
4
The Conometric Final Caps are to be cemented into the final crown to provide friction retention to the abutment. They are made of gold-shaded titanium and are available in the diameter of 3.3 and 4.5 mm.
The Conometric Temporization Caps provide support of immediate and short term provisional prosthetic restorations on Conometric Abutments up to 6 months. The temporary caps are provided with the diameter 3.3 mm and 4.5 mm and are manufactured of PEEK material. The smaller cap (Ø 3.3 mm) also contains titanium alloy.
The Conometric Healing Caps protect the Conometric Abutment until a crown is placed and serve for the shaping of the gingiva. The Healing Caps are made of PEEK polymer and available with an diameter of 3.3 mm and 4.5 mm. Regarding the outer geometries, the Healing Caps are presented as a wide variant with an maximum outer diameter of 6.0 mm and - for the Healing Cap Ø 3.3 mm - also as a small version with an maximum outer diameter of 4.8 mm.
5.0 Indications for Use:
The Conometric Abutments are intended to be used in conjunction with the Conometric Final Cap and Ankylos C/X implants, OsseoSpeed EV implants, and Xive S implants to support fixed friction retained single crowns, in mandible or maxilla, in a partially or completely edentulous patient. This system is intended for delayed loading. The Conometric Abutment including the abutment screw and the Conometric Final Cap make up the final abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
5
- Substantial Equivalence: 6.0
Technological Characteristics:
An overview of the similarities and differences between the subject and predicate devices is given in Table 5.1 below. A discussion of the similarities and differences follows Table 5.1.
| Table 5.1: Similarities and Differences between proposed and predicate Conometric Abutments | ||
|---|---|---|
| Element | Proposed Device | |
| Conometric Abutments | Predicate Device | |
| Ankylos® C/X Dental Implant System | ||
| (Ankylos® Regular Abutments) | ||
| K140347 | ||
| Manufacturer | Dentsply Sirona | Dentsply Sirona |
| Indications for | ||
| Use | The Conometric Abutments are intended to be | |
| used in conjunction with the Conometric Final | ||
| Cap and Ankylos C/X implants, OsseoSpeed | ||
| EV implants, and Xive S implants to support | ||
| fixed friction retained single crowns, | ||
| in | ||
| mandible or maxilla, in a partially | ||
| or | ||
| completely edentulous patient. This system is | ||
| intended for delayed loading. The Conometric | ||
| Abutment including the abutment screw and | ||
| the Conometric Final Cap make up the final | ||
| abutment. The abutment screw is intended to | ||
| secure the abutment to the endosseous implant. | ANKYLOS® C/X Implants of 8 mm in length | |
| or longer are for single-stage or two-stage | ||
| surgical procedures and cemented, removable | ||
| or screw retained restorations. The | ||
| ANKYLOS® C/X Implants may be used for | ||
| immediate placement and function on single | ||
| tooth and/or multiple tooth applications when | ||
| adequate primary stability is achievable, with | ||
| appropriate occlusal loading, in order to | ||
| restore chewing function. Multiple tooth | ||
| applications may be splinted. |
ANKYLOS® C/X Implants of 6.6 mm in
length are for two-stage surgical procedures
and cemented, removable or screw retained
restorations. The ANKYLOS® C/X Implants
may be used for immediate placement on
single tooth and/or multiple tooth applications
when adequate primary stability is achievable,
with appropriate occlusal loading, in order to
restore chewing function. Multiple tooth
applications may be splinted. |
| Intended use of
concerned
abutments | Prosthetic restoration | Prosthetic restoration |
| Compatible
Implants | Ankylos® C/X Implants (K140347)
XiVE® S plus Implants (K073075)
OsseoSpeed™ EV Implants (K120414) | Ankylos® C/X Implants (K140347) |
6
| Table 5.1: Similarities and Differences between proposed and predicate Conometric Abutments | ||||
|---|---|---|---|---|
| Element | Proposed Device | |||
| Conometric Abutments | Predicate Device | |||
| Ankylos® C/X Dental Implant System | ||||
| (Ankylos® Regular Abutments) | ||||
| K140347 | ||||
| Implant- | ||||
| Abutment | ||||
| Connection | Ankylos: tapered | |||
| OsseoSpeed™EV: tapered | ||||
| XiVE: hexagonal | tapered | |||
| Material | Titanium Alloy | Titanium Alloy | ||
| Gingiva Height | ||||
| of Abutments | Ankylos®: 1.5mm, 3.0mm, 4.5mm | |||
| ATISTM EV: 1.0mm, 2.0mm, 3.0mm | ||||
| XiVE®: 1.0mm, 2.0mm, 3.0 mm | 0.75mm, 1.5mm, 3.0mm, 4.5mm | |||
| Angulation of | ||||
| Abutments | 0°, 15° | 0°, 7.5°, 15°, 22.5° | ||
| Abutment | ||||
| design | two-piece abutment connected by screw/ | |||
| one-piece abutment | two-piece abutment connected by screw | |||
| Prosthetic | ||||
| restoration | single-unit | single-unit, multi-unit | ||
| Fixation of | ||||
| Superstructure | retained by taper friction | screw-retained or cement retained | ||
| Sites in the | ||||
| body | Mandible / maxilla | Mandible / maxilla | ||
| Reusability | single use | single use | ||
| Delivery | Ankylos® and XiVE®: non-sterile | |||
| OsseoSpeed™ EV: sterile | Implants: sterile | |||
| Abutments: non-sterile |
The indications for use of the subject Conometric Abutments and the predicate device cleared under premarket notification K140347 are similar. Both the subject device and the predicate device (K140347) are intended for single tooth restorations. The indicated use of the subject Conometric Abutments are a subset of the predicate device (K140347) in that the predicate device is also indicated for multiple tooth restorations. Though, the indicated use of the Conometric Abutments does not contain reference to proposed implants. Both the subject Conometric Abutments and the abutments of the predicate device system (K140347) are composed of titanium alloy, intended for both maxillary and mandibular use, and are offered in angulations of 0° and 15°. The abutments of the predicate device system are additionally offered in angulations of 7.50 and 22.50.
While abutments of the predicate device system (K140247) are intended for screw-retained and cement retained restorations, the subject Conometric Abutments are intended for friction retained restorations. Performance testing is included to support substantial equivalence with the respect to the difference in restoration retention.
While the abutments offered with the predicate implant system (K140347) are designed for use with implants of the predicate device system, the subject Conometric Abutments are offered in variants designed for use with implants if the predicate Ankylos C/X Implant System (K140347), as well as, implants of the reference device Osseosped EV (K120414) and XiVE S (K073075) implant systems. Performance testing is included to support the compatibility of the subject Conometric Abutments, in their worst-case configuration, with the predicate and reference device implants.
7
7.0 Non-Clinical Performance Data:
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes:
- · Fatigue Testing: Dynamic fatigue testing was conducted on the worst case construct of the subject abutment (including the Conometric Final Cap) and predicate devices according to ISO 14801 Dental- implants Dynamic Fatigue Test for Endosseous Dental Implants
- · The friction based retention of the proposed Conometric Abutments was tested under dynamic load. The defined acceptance criteria were fulfilled.
- · Pull-out Test: The removal torque of implants after several removal procedures of the Final Cap from the Conometric Abutment have been measured in synthetic bone and compared with test and literature data regarding insertion torque of the Final Cap onto the abutment, removal torques of standard prosthetic restorations (cemented crown) and the pull-out forces of osseointegrated implants. The results showed that the proposed Conometric Abutment system perform as intended.
- · Biocompatibility: Material and manufacturing of the proposed Conometric Abutments are identical to those of the predicate device. Thus, biocompatibility data are referenced to support substantial equivalence. Biocompatibility of the Conometric Final Cap, Conometric Temporization Cap and the Conometric Healing Caps, consisting of same material as the predicate devices, have been proved by testing according to ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of materials.
- · Sterilization: Sterilization validation of sterile devices is referenced by equivalence (and supported by technical equivalence rationale) to sterilization validation of existing worst-case challenge validations conducted according to ISO 11137-1 Sterilization of health care products --Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose which conclude that a sterility assurance level (SAL) of 10-6 is achieved under the sterilization process parameters utilized.
- · Moist heat validation sterilization parameters of non-sterile components were validated by equivalence to sterilization of existing worst-case challenge validations conducted 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 ISO17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1demonstrating a sterility assurance level (SAL) of 10-6.
- · Packaging and materials are the same as used for the predicate devices. Thus, shelf life data are referenced to support substantial equivalence.
8
Clinical Performance Data 8.0 -
No human clinical data was included in this premarket notification to support the substantial equivalence of the subject Conometric Abutments.
Conclusion Regarding Substantial Equivalence 9.0 -
The proposed Conometric Abutments are endosseous dental implant abutments which are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible. The proposed devices incorporate the same fundamental technology and intended use as the predicate device and have been proposed for similar indications for use.
Non-clinical bench testing has been conducted and included in this premarket notification to demonstrate the performance of the proposed Conometric Abutments against their design, functional, and safety requirements. The comparison of the intended use, indications for use, technological characteristics, with the inclusion of the results of nonclinical testing, support a conclusion of substantial equivalence of the Conometric Abutments to the predicate device.