(128 days)
No
The device description focuses on CAD/CAM fabrication of patient-specific abutments based on clinician prescription, with no mention of AI or ML for design or analysis.
No
The device is described as an endosseous dental implant abutment intended to support a prosthetic device. Its function is primarily structural (supporting a prosthesis) rather than directly therapeutic (treating a disease or condition).
No
Explanation: The provided text describes the ATLANTIS® Abutment as a device intended to support prosthetic devices in edentulous patients, functioning as a substructure or final restoration. It is a physical component used in dental implants for structural support, not for diagnosing medical conditions.
No
The device description clearly states that the device is an endosseous dental implant abutment, which is a physical component fabricated using CAD/CAM technology. The performance studies also involve physical testing (static and dynamic compression-bending).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The ATLANTIS® Abutment is a dental implant component intended to support prosthetic devices in the mouth. It is a physical device implanted into the body, not used to test bodily specimens.
- Intended Use: The intended use clearly describes supporting prosthetic devices in edentulous patients, which is a mechanical and structural function within the body.
The device is a medical device, specifically a dental implant abutment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATLANTIS® Abutment is intended for use with an endosseous implant 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 mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.
The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.
The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment. The abutment. The abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.
ATLANTIS® Abutment for MIS implant is compatible with MIS implant System. MIS short implants (6mm) are to be used only with straight abutments.
ATLANTIS® products are compatible with the implants shown in the table below.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The proposed ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) and three designs: ATLANTIS® Abutment for MIS Implant, ATLANTIS® Crown Abutment for MIS Implant and ATLANTIS® Conus Abutment for MIS Implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at Dentsply Implant manufacturing sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.
The coronal portion of the ATLANTIS® Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment or ATLANTIS® Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS® Crown Abutment). The ATLANTIS® abutment interface is compatible with the MIS implants from the MIS Implant System (K040807) and MIS implants from MIS Short Implants (K103089).
The MIS M4 & SEVEN implant interface has an internal hex connection and provided for implant platform diameter Narrow (3.30 mm), Standard (3.75 and 4.20 mm) and Wide (5.0 and 6.0 mm). The abutment height ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutment is provided straight and up to 30° of angulation.
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
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)
Non-clinical test data and analyses are included to support substantial equivalence:
- Static and dynamic compression-bending testing conducted according to ISO 14801: Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.
- Geometric analyses conducted on implant bodies, abutments, and screws to support the dimensional compatibility of the ATLANTIS® Abutment for MIS Implant with the MIS Implant Technologies, Inc., Narrow (Ø3.30 mm), Standard (Ø3.75 and 4.2 mm), and Wide (Ø5.0 and 6.0 mm), M4 and SEVEN implant platforms.
- Sterilization parameters which have 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 20857: Sterilization of health care products -- Dry heat --Requirements for the development, validation and routine control of a sterilization process for medical devices are included and are as referenced in the predicate device (K160626).
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
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November 30, 2017
Dentsply Sirona Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K172225
Trade/Device Name: ATLANTIS® Abutment for MIS Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 31, 2017 Received: September 1, 2017
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. 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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Andrew I. Steen -S
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) K172225
Device Name ATLANTIS® Abutment for MIS Implant
Indications for Use (Describe)
The ATLANTIS® Abutment is intended for use with an endosseous implant 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 mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.
The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.
The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment. The abutment. The abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.
ATLANTIS® Abutment for MIS implant is compatible with MIS implant System. MIS short implants (6mm) are to be used only with straight abutments.
ATLANTIS® products are compatible with the implants shown in the table below.
| Implant manufacturer | MIS-IMPLANT TECHNOLOGIES INC |
|---|---|
| ---------------------- | ------------------------------ |
| Trade Name | Abutment Platform Diameter | Implant Diameter |
|---|---|---|
| MIS Implant M4 & SEVEN Narrow Platform | Ø3.30 mm | Ø3.30 mm |
| MIS Implant M4 & SEVEN Standard Platform | Ø3.75 and 4.2 mm | Ø3.75 and 4.2 mm |
| MIS Implant M4 & SEVEN Wide Platform | Ø5.0 and 6.0 mm | Ø5.0 and 6.0 mm |
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
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a curved leaf or wave in gray. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, both in a simple, sans-serif font, also in gray. The overall design is clean and modern.
SECTION 5. 510(k) SUMMARY K172225
ATLANTIS® Abutment for MIS Implant
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
| Date Prepared: | November 30, 2017 |
2. Device Name:
- Proprietary Name: .
- Classification Name: ●
- Endosseous dental implant abutment CFR Number: 21 CFR 872.3630
- Device Class: .
- II Product Code: NHA
3. Predicate Device:
●
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| ATLANTIS® Abutment for | ||
| HIOSSEN ET | ||
| Implant | K160626 | DENTSPLY IMPLANTS |
| MIS Dental Implant System | ||
| (Reference Predicate Device) | K040807 | MIS-IMPLANT TECHNOLOGIES INC |
| MIS Short Implants | ||
| (Reference Predicate Device) | K103089 | MIS-IMPLANT TECHNOLOGIES INC |
ATLANTIS® Abutment for MIS Implant
4. Description of Device:
The proposed ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) and three designs: ATLANTIS® Abutment for MIS Implant, ATLANTIS® Crown Abutment for MIS Implant and ATLANTIS® Conus Abutment for MIS Implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at Dentsply Implant manufacturing sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.
4
| Table 5-1: Compatibility table (The ATLANTIS® Abutment Titanium, Zirconia and Gold-
| shaded are compatible with MIS implant interface (Ø3.3, 3.75, 4.2, 5.0 and 6.0 mm) | |||||
|---|---|---|---|---|---|
| Implant | |||||
| Manufacturer | Interface | ATLANTIS® | |||
| Abutment | |||||
| for MIS | |||||
| Implant | ATLANTIS® | ||||
| Crown | |||||
| Abutment | |||||
| for MIS | |||||
| Implant | ATLANTIS® | ||||
| Conus | |||||
| Abutment | |||||
| for MIS | |||||
| Implant | |||||
| (Custom) | ATLANTIS® | ||||
| Conus | |||||
| Abutment for | |||||
| MIS implant | |||||
| (Overdenture) | |||||
| MIS-IMPLANT | |||||
| TECHNOLOGIES | |||||
| INC | MIS M4 & | ||||
| SEVEN Implant | |||||
| System (MIS | |||||
| implant) (Ø3.3, | |||||
| 3.75, 4.2, 5.0 and | |||||
| 6.0 mm) | Titanium, | ||||
| Zirconia, | |||||
| Gold-shaded | |||||
| Titanium | |||||
| (Gold-Hue) | Titanium, | ||||
| Zirconia | Titanium, | ||||
| Gold-shaded | |||||
| Titanium | |||||
| (Gold-Hue) | Titanium |
The coronal portion of the ATLANTIS® Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment or ATLANTIS® Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS® Crown Abutment). The ATLANTIS® abutment interface is compatible with the MIS implants from the MIS Implant System (K040807) and MIS implants from MIS Short Implants (K103089).
The MIS M4 & SEVEN implant interface has an internal hex connection and provided for implant platform diameter Narrow (3.30 mm), Standard (3.75 and 4.20 mm) and Wide (5.0 and 6.0 mm). The abutment height ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutment is provided straight and up to 30° of angulation.
5
- న. Indications for Use:
The ATLANTIS® Abutment is intended for use with an endosseous implant 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 mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.
The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.
The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.
ATLANTIS® Abutment for MIS implant is compatible with MIS implant from MIS Implant System. MIS short implants (6mm) are to be used only with straight abutments.
ATLANTIS® products are compatible with the implants shown in the table below.
| Trade Name | Abutment Platform Diameter | Implant Diameter |
|---|---|---|
| MIS Implant M4 & SEVEN | ||
| Narrow Platform | Ø3.30 mm | Ø3.30 mm |
| MIS Implant M4 & SEVEN | ||
| Standard Platform | Ø3.75 and 4.2 mm | Ø3.75 and 4.2 mm |
| MIS Implant M4 & SEVEN | ||
| Wide Platform | Ø5.0 and 6.0 mm | Ø5.0 and 6.0 mm |
Implant manufacturer – MIS-IMPLANT TECHNOLOGIES INC
6
6. Substantial Equivalence:
Technological Characteristics
ATLANTIS® Abutment for MIS implant is a patient specific restorative device designed under the control of Dentsply Implants and manufactured by Dentsply Implants using CAD/CAM technology.
Table 5-2 and 5-3 below summarizes the differences and similarities of the subject and predicate devices.
| Table 5-2: Indications for use for the proposed and the predicate devices | ||||
|---|---|---|---|---|
| ATLANTIS® Abutment for | ||||
| MIS Implant | ||||
| (Proposed Device) | ATLANTIS® Abutment for | |||
| HIOSSEN ET Implant (K160626) | ||||
| (Primary Predicate) | MIS Dental Implant System | |||
| (K040807) | ||||
| (Reference Predicate) | MIS Short Implants | |||
| (K103089) | ||||
| (Reference Predicate) | Summary of differences in the | |||
| indications for use | ||||
| The ATLANTIS® Abutment is intended | ||||
| for use with an endosseous implant 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 mandible or maxilla. | ||||
| The prosthesis can be cemented or | ||||
| screw retained to the abutment. The | ||||
| abutment screw is intended to secure | ||||
| the ATLANTIS® Abutment to the | ||||
| endosseous implant. |
The ATLANTIS® Crown Abutment
is intended for use with an endosseous
implant to function as a substructure
that also serves as the final
restoration, in a partially or
completely edentulous patient. The
abutment screw is intended to secure
the ATLANTIS® Crown Abutment to
the endosseous implant.
The ATLANTIS® Conus Abutment
is intended for use with an endosseous
implant to support a prosthetic device
in partially or completely edentulous
patients. It is intended for use to | The ATLANTIS® Abutment is intended
for
use with an endosseous implant 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 mandible or
maxilla. The prosthesis can be cemented
or screw retained to the abutment. The
abutment screw is intended to secure the
ATLANTIS® Abutment to the
endosseous implant.
The ATLANTIS® Crown Abutment is
intended for use with an endosseous
implant to function as a substructure
that also serves as the final restoration,
in a partially or completely edentulous
patient. The abutment screw is intended
to secure the ATLANTIS® Crown
Abutment to the endosseous implant.
The ATLANTIS® Conus Abutment is
intended for use with an endosseous
implant to support a prosthetic device in
partially or completely edentulous
patients. It is intended for use to support
a removable multiple tooth prosthesis,
in the mandible or maxilla. The | The MIS Dental Implant
System is indicated for use in
surgical and restorative
applications for placement in the
bone of the upper or lower jaw
to provide support for prosthetic
devices, such as artificial teeth,
in order to restore the patient's
chewing function. | MIS Dental Implants are intended
to be surgically placed in the bone
of the upper or lower jaw arches to
provide support for prosthetic
devices, such as artificial teeth, in
order to restore a patient's chewing
function.
When a one stage surgical
procedure is applied, the implant
may be immediately loaded when
good primary stability is achieved
and the occlusal load is
appropriate. MIS short implants are
to be used only with straight
abutments. | The indications for use of the
proposed device are similar to
the indications for use of the
primary predicate device. The
difference is that the indications
for use of the primary predicate
device are for Hiossen ET
implant system.
The indications for use of the
reference predicate device cover
the entire dental system. The
indications for use are similar.
The difference between the
proposed device and the
reference predicate device is that
the prosthesis, in addition to
screw-retained restoration or
cement retained restoration, can
be attachment-retained (friction
fit) to the proposed device. |
7
| Table 5-2: Indications for use for the proposed and the predicate devices | | | | | | MIS Dental
Implant System
(K040807)
(Reference
Predicate) | MIS Short Implants
(K103089)
(Reference Predicate) | Summary of
differences in
the
indications
for use | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------|--|
| ATLANTIS® Abutment for
MIS implant
(Proposed Device) | ATLANTIS® Abutment for HIOSSEN ET
Implant (K160626)
(Primary Predicate) | | prosthesis, in the mandible or maxilla.
The prosthesis is attachment-retained by
friction fit to the abutment. The abutment
screw is intended to secure the
ALTLANTIS® Conus Abutment to the
endosseous implant. | | friction fit to the abutment. The abutment screw is
intended to secure the ATLANTIS® Conus
Abutment to the endosseous implant. | | | | |
| ATLANTIS® Abutment for MIS Implant
is compatible with MIS implant from
MIS Implant System. MIS short implants
(6mm) are to be used only with straight
abutments.
ATLANTIS® products are compatible
with the implants shown in the table
below.
Implant manufacturer:
MIS IMPLANT TECHNOLOGIES, INC | ATLANTIS® products are compatible with the
implants shown in the table below.
Implant Manufacturer:
HIOSSEN INC | | | | | | | | |
| Trade Name | Abutment
Platform
Diameter | Implant
Diameter | Trade Name | Abutment
Platform
Diameter | Implant
Diameter | | | | |
| MIS Implant M4
& SEVEN
Narrow Platform | Ø3.30 mm | Ø3.30 mm | HIOSSEN ET III SA
Fixture Mini | Ø3.5mm | Ø3.5mm | | | | |
| MIS Implant
M4 & SEVEN
Standard
Platform | Ø3.75 and
4.2 mm | Ø3.75 and
4.2 mm | HIOSSEN ET III SA
Fixture Regular | Ø4.0, 4.5,
5.0, 6.0,7.0 mm | Ø4.0, 4.5, 5.0,
6.0, 7.0 mm | | | | |
| MIS Implant
M4 & SEVEN
Wide Platform | Ø5.0 and
6.0 mm | Ø5.0 and
6.0 mm | | | | | | | |
8
| Table 5-3: Similarities and differences between the proposed and the predicate devices | |||||
|---|---|---|---|---|---|
| Element | Proposed Device | ||||
| ATLANTIS® Abutment | |||||
| for MIS Implant | Primary Predicate Device | ||||
| ATLANTIS® Abutment for | |||||
| HIOSSEN ET Implant | Reference Predicate Device | ||||
| MIS Dental Implant | |||||
| System | Reference Predicate Device | ||||
| MIS Short Implants | Summary of differences | ||||
| 510(k) | To be assigned | K160626 | K040807 | K103089 | - |
| Prosthesis | |||||
| Attachment | Screw-retained | ||||
| Cement-retained | |||||
| Friction Fit | Screw-retained | ||||
| Cement-retained | |||||
| Friction Fit | Screw-retained | ||||
| Cement-retained | Screw-retained | ||||
| Cement-retained | No difference between the proposed | ||||
| and the primary predicate device. | |||||
| The reference device does not | |||||
| indicate friction fit. | |||||
| Restoration | |||||
| Abutment | |||||
| Platform | |||||
| Diameter | Single or Multi-unit | ||||
| 3.3, 3.75, 4.2, 5.0, 6.0 | Single or Multi-unit | ||||
| 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 | Single or Multi-unit | ||||
| 3.3, 3.75, 4.2, 5.0, 6.0 | Single or Multi-unit | ||||
| 4.2, 5.0, 6.0 | No difference | ||||
| The proposed device is designed to | |||||
| fit the MIS interface. | |||||
| Therefore, no difference between the | |||||
| proposed device and the reference | |||||
| predicate device. |
| Table 5-3: Similarities and differences between the proposed and the predicate devices | |||||||
|---|---|---|---|---|---|---|---|
| Element | Proposed Device | ||||||
| ATLANTIS® Abutment | |||||||
| for MIS Implant | Primary Predicate Device | ||||||
| ATLANTIS® Abutment for | |||||||
| HIOSSEN ET Implant | Reference Predicate Device | ||||||
| MIS Dental Implant | |||||||
| System | Reference Predicate Device | ||||||
| MIS Short Implants | Summary of differences | ||||||
| Abutment | |||||||
| angle | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | Straight | No difference | ||
| Connection | Internal hex connection | Internal hex connection | Internal hex connection | Internal hex connection | There is no difference between the | ||
| proposed device and the reference | |||||||
| predicate device. | |||||||
| Material | |||||||
| Implant | NA | NA | Titanium Alloy | ||||
| Ti 6Al 4V ELI | Titanium Alloy | The proposed device is an abutment | |||||
| Material: | |||||||
| Abutment | Titanium alloy, Zirconia | Titanium alloy, Zirconia | Titanium alloy | Titanium Alloy | No difference | ||
| Material: | |||||||
| Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | No difference |
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7. Non-Clinical Performance Data
Non-clinical test data and analyses are included to support substantial equivalence:
- . Static and dynamic compression-bending testing conducted according to ISO 14801: Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.
- Geometric analyses conducted on implant bodies, abutments, and screws to support the dimensional compatibility of the ATLANTIS® Abutment for MIS Implant with the MIS Implant Technologies, Inc., Narrow (Ø3.30 mm), Standard (Ø3.75 and 4.2 mm), and Wide (Ø5.0 and 6.0 mm), M4 and SEVEN implant platforms.
- Sterilization parameters which have 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 20857: Sterilization of health care products -- Dry heat --Requirements for the development, validation and routine control of a sterilization process for medical devices are included and are as referenced in the predicate device (K160626).
Biocompatibility
The material composition and manufacturing processing methods of the subject ATLANTIS® Abutment for MIS Implant are identical to the predicate device, ATLANTIS® Abutment for Hiossen ET Implant (K160626). Therefore, no additional biocompatibility data is included to support substantial equivalence.
8. Conclusion Regarding Substantial Equivalence
The ATLANTIS® Abutment for MIS Implant is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTIS® Abutment for MIS Implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicates, ATLANTIS® Abutment for HIOSSEN ET Implant (K160626), MIS Dental Implant System (K040807) and MIS Short Implants (K103089). Test data to verify the performance of the ATLANTIS® Abutment for MIS Implant has been provided with mechanical testing. The results of the test studies and dimensional compatibility analyses, combined with the design, and intended use comparison with the predicate devices, support substantial equivalence.