(76 days)
No
The summary describes a physical dental implant abutment fabricated using CAD/CAM technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an abutment for dental implants, intended to support prosthetic devices. It functions as a structural component for dental restorations. While it aids in replacing lost teeth, its primary purpose is mechanical support rather than directly treating a disease or condition. The healing abutment is for temporary use during soft tissue healing, which is part of the recovery process after surgery, not a therapeutic treatment itself.
No
This device is a dental implant abutment, intended to support a prosthetic device. It does not provide any diagnostic function.
No
The device description explicitly states that the proposed devices are "endosseous dental implant abutments" and details their material composition (Titanium, Gold-shaded Titanium). This indicates the device is a physical hardware component, not software only. While CAD/CAM technology is mentioned for fabrication, the final product is a physical abutment.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The text clearly describes the ATLANTIS® Abutment and its variations as dental implant components intended to support prosthetic devices in the mouth. They are physical devices used in a surgical and restorative procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information about a patient's health status.
The device is a medical device used in dentistry for the physical support of dental prosthetics.
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-retained by friction fit to the abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.
The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.
ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System.
ATLANTIS® products are compatible with the implants shown in the table below.
Product codes
NHA
Device Description
The proposed ATLANTIS® Abutments for MIS Conical Connection Implant are endosseous dental implant abutments.
The proposed devices are compatible with:
- MIS V3 conical connection narrow and standard dental implant diameters Ø3.3, 3.9, 4.3 and a. 5.0 mm (K163349)
- b. MIS C1 narrow, standard and wide platform conical connection implant diameters Ø3.3, 3.75, 4.2, and 5.0 (K172505, K112162)
The abutments are available in four (4) designs:
- ATLANTIS® Abutment for MIS Conical Connection Implant, a.
- ATLANTIS® Crown Abutment for MIS Conical Connection Implant, b.
- ATLANTIS® Conus Abutment (Custom or Overdenture) for MIS Conical Connection C. Implant
- d. ATLANTIS® Healing Abutment for MIS Conical Connection Implant
The materials composition of the proposed devices are described below in Table 5.2.
Abutment: ATLANTIS® Abutment for MIS Conical Connection Implant, ATLANTIS® Crown Abutment for MIS Conical Connection Implant, ATLANTIS® Conus Abutment (Custom) for MIS Conical Connection Implant, ATLANTIS® Conus Abutment (Overdenture) for MIS Conical Connection Implant, ATLANTIS® Healing Abutment for MIS Conical Connection Implant
Materials: Titanium, Gold-shaded Titanium (Gold-Hue)
The maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutments are provided straight and up to 30° of angulation.
All proposed abutments are patient-specific abutments fabricated using CAD/CAM technology by Dentsply Sirona Implants. 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® Abutments for MIS Conical Connection Implant can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment for MIS Conical Connection Implant or ATLANTIS® Conus Abutment for MIS Conical Connection Implant), fabricated as a single tooth final restoration onto which porcelain is added ATLANTIS® Crown Abutment for MIS Conical Connection Implant) or fabricated with a short core for soft tissue healing (ATLANTIS® Healing Abutment).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla (oral cavity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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 performance data included:
- Fatigue testing: conducted according to ISO 14801: Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants. Fatigue test results were compared to the predicate and reference devices.
- Geometric compatibility analysis: conducted on OEM implant bodies, OEM abutments, and OEM screws to support the dimensional compatibility of the ATLANTIS® Abutment for MIS Conical Connection Implant with the MIS V3 implants (Narrow: Ø3.3mm and Standard: Ø3.9, 4.3, 5.0mm) and MIS C1 implants (Narrow Ø3.3mm, Standard: Ø3.75, 4.2mm and Wide: Ø5.0, 6.0 mm).
- Sterilization validation: referenced by equivalency to the sterilization validation of predicate (K172225). Predicate device was 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.
- No additional biocompatibility data was included as material composition and manufacturing processing methods are identical to the predicate device.
No human clinical data was included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K160626, K163349, K172505, K112162
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
March 5, 2020
Dentsply Sirona Karl Nittinger Vice President, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K193529
Trade/Device Name: ATLANTIS® Abutment for MIS Conical Connection Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 19, 2019 Received: December 20, 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 (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
Indications for Use
510(k) Number (if known) K193529
Device Name
ATLANTIS® Abutment for MIS Conical Connection Implants
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-retained by friction fit to the abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.
The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.
ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System.
ATLANTIS® products are compatible with the implants shown in the table below.
| Implant manufacturer - MIS-IMPLANT TECHNOLOGIES INC | |
|---|---|
| Trade Name | Abutment Platform Diameter |
| Atlantis Abutment for MIS V3 NP | Ø2.765mm |
| Atlantis Abutment for MIS C1 NP | Ø2.76mm |
| Atlantis Abutment for MIS C1 & V3 SP | Ø3.16mm |
| Atlantis Abutment for MIS C1 WP | Ø4.01mm |
Implant Diameter V3: Ø3.30 mm C1: Ø3.30 mm C1: Ø3.75,4.2 mm, V3: Ø3.90,4.3,5.0 mm C1: Ø5.0 mm
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/4/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, segmented leaf or a stylized letter 'S'. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned with the right edge of the abstract shape.
510(k) SUMMARY K193529 ATLANTIS Abutment for MIS Conical Connection Implants
-
- Submitter Information:
Dentsply Sirona Inc. 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: | 05 March 2020 |
2. Device Identification:
- . Proprietary Name: ATLANTIS® Abutment for MIS Conical Connection Implants ● Classification Name: Endosseous dental implant abutment ● CFR Number: 21 CFR 872.3630 Device Class: Class II ●
- . Product Code: NHA
3. Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| ATLANTIS® Abutment for MIS | ||
| Implant | K172225 | MIS Implants Technologies LTD |
| (Dentsply Sirona) | ||
| Reference Devices: | ||
| ATLANTIS® Abutment for | ||
| HIOSSEN ET Implant | K160626 | Dentsply Sirona Implants |
| MIS V3 Conical Connection Dental | ||
| Implant System | K163349 | MIS Implants Technologies LTD |
| (Dentsply Sirona) | ||
| MIS C1 Narrow Platform Conical | ||
| Connection Implant System, MIS C1 | ||
| Wide Platform Conical Connection | ||
| Abutment | K172505 | MIS Implants Technologies LTD |
| (Dentsply Sirona) | ||
| MIS C1 Standard Platform Conical | ||
| Connection Dental Implant system | ||
| MIS C1 Wide Platform Conical | ||
| Connection Dental Implant system | K112162 | MIS Implants Technologies LTD |
| (Dentsply Sirona) |
The proposed ATLANTIS® Abutments for MIS Conical Connection Implant are compatible with Implant Systems cleared in the reference devices K172505, K112162, and K163349.
5
-
- Device Description
The proposed ATLANTIS® Abutments for MIS Conical Connection Implant are endosseous dental implant abutments.
- Device Description
The proposed devices are compatible with:
- MIS V3 conical connection narrow and standard dental implant diameters Ø3.3, 3.9, 4.3 and a. 5.0 mm (K163349)
- b. MIS C1 narrow, standard and wide platform conical connection implant diameters Ø3.3, 3.75, 4.2, and 5.0 (K172505, K112162)
Refer to Table 5.1 for the implants the proposed ATLANTIS® Abutments for MIS Conical Connection Implant are compatible with.
| Table 5.1 Implant systems which proposed ATLANTIS® Abutments for MIS Conical Connection
| Implant are compatible with. | ||
|---|---|---|
| Trade Name | Abutment Platform Diameter | Implant Diameter |
| Atlantis Abutment for MIS V3 NP | Ø2.765mm | V3: Ø3.30 mm |
| Atlantis Abutment for MIS C1 NP | Ø2.76mm | C1: Ø3.30 mm |
| Atlantis Abutment for MIS C1 & V3 SP | Ø3.16mm | C1: Ø3.75, 4.2 mm |
| V3: Ø3.90, 4.3, 5.0 mm | ||
| Atlantis Abutment for MIS C1 WP | Ø4.01mm | C1: Ø5.0 mm |
The abutments are available in four (4) designs:
- ATLANTIS® Abutment for MIS Conical Connection Implant, a.
- ATLANTIS® Crown Abutment for MIS Conical Connection Implant, b.
- ATLANTIS® Conus Abutment (Custom or Overdenture) for MIS Conical Connection C. Implant
- d. ATLANTIS® Healing Abutment for MIS Conical Connection Implant
The materials composition of the proposed devices are described below in Table 5.2.
| Table 5.2 ATLANTIS® Abutment for MIS Conical Connection Implant Materials | |||||
|---|---|---|---|---|---|
| Abutment | ATLANTIS® | ||||
| Abutment for | |||||
| MIS Conical | |||||
| Connection | |||||
| Implant | ATLANTIS® | ||||
| Crown | |||||
| Abutment for | |||||
| MIS Conical | |||||
| Connection | |||||
| Implant | ATLANTIS® | ||||
| Conus | |||||
| Abutment | |||||
| (Custom) for | |||||
| MIS Conical | |||||
| Connection | |||||
| Implant | ATLANTIS® | ||||
| Conus | |||||
| Abutment | |||||
| (Overdenture) | |||||
| for MIS | |||||
| Conical | |||||
| Connection | |||||
| Implant | ATLANTIS® Healing | ||||
| Abutment | |||||
| for MIS Conical | |||||
| Connection Implant | |||||
| Materials | Titanium, Gold-shaded Titanium (Gold-Hue) | Titanium | Titanium, Gold-shaded Titanium (Gold-Hue) | Titanium | Titanium, Gold-shaded Titanium (Gold-Hue) |
6
The maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutments are provided straight and up to 30° of angulation.
All proposed abutments are patient-specific abutments fabricated using CAD/CAM technology by Dentsply Sirona Implants. 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® Abutments for MIS Conical Connection Implant can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment for MIS Conical Connection Implant or ATLANTIS® Conus Abutment for MIS Conical Connection Implant), fabricated as a single tooth final restoration onto which porcelain is added ATLANTIS® Crown Abutment for MIS Conical Connection Implant) or fabricated with a short core for soft tissue healing (ATLANTIS® Healing Abutment).
-
- 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.
- Indications for Use
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.
The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.
ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System.
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 |
| Atlantis Abutment for MIS V3 NP | Ø2.765mm | V3: Ø3.30 mm |
| Atlantis Abutment for MIS C1 NP | Ø2.76mm | C1: Ø3.30 mm |
| Atlantis Abutment for MIS C1 & V3 SP | Ø3.16mm | C1: Ø3.75,4.2 mm, |
| V3: Ø3.90,4.3,5.0 mm | ||
| Atlantis Abutment for MIS C1 WP | Ø4.01mm | C1: Ø5.0 mm |
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6. Substantial Equivalence Discussion
ATLANTIS® Abutment for MIS Conical Connection Implant is a patient specific restorative device designed by Dentsply Sirona Implants technicians and manufactured by Dentsply Sirona Implants using CAD/CAM technology.
With the exception of the abutment to implant interface geometry, the design of the ATLANTIS® Abutment for MIS Conical Connection Implant, ATLANTIS® Conus Abutment for MIS Conical Connection Implant, and ATLANTIS® Crown Abutment for MIS Conical Connection Implant are identical to the design of the predicate ATLANTIS® Abutment for MIS Implant (K172225). Both the proposed ATLANTIS® Abutment for MIS Conical Connection Implants and the predicate device (K172225) are composed of the identical titanium allov conforming to ASTM F136 (Standard Specification for Wrought Titanium-6 Alumin-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications) and are both offered in a "Gold Hue" variants which feature a titanium nitride coating to produce a gold-shaded external surface. The difference in implant connection interface geometry is due to the compatibility requirement of the proposed devices with the specified MIS Conical Connection Implants (versus that of the predicate device (K172225) which feature implant interface geometry designed for compatibility with MS Internal Hex Implants). Dynamic fatigue testing to international standard ISO 14801 (Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants) has been conducted and is included in support of substantial equivalence with respect to the difference in implant interface geometry.
The abutment platform diameter range of the proposed devices is similar to that of the predicate device (K172225). Differences in abutment platform diameter do not impact substantial equivalence in that abutment platform diameter changes according to the corresponding platform connection. However, specifications, including abutment diameter, of the final, finished abutment are identical for all ATLANTIS® abutments.
The design of the ATLANTIS® Healing Abutment is similar to the design of the predicate. V3 Conical Connection Healing Caps (K163349). The differences in height above the margin do not affect substantial equivalence as the healing abutment is used only in the healing phase and does not carry any load. In the case of the subject ATLANTIS Healing Abutment, the healing cap diameter is the customized, patient-specific portion of the healing cap.
The design specifications of the final, finished patient-specific design of the proposed ATLANTIS® Abutment for MIS Conical Connections Implants are identical to those of the predicate ATLANTIS® Abutment for MIS Implant cleared under K172225. The final design of both the proposed and predicate (K172225) adhere to the same design limitations within the final patient-specific design, including: maximum abutment angulation of 30°, maximum abutment height of 15 mm above the implant interface, maximum abutment post height above the trans-mucosal collar of 4 mm, as well as, final abutment width of 3.3 mm to 6.5 mm.
The proposed devices have the identical intended use, are manufactured using the identical materials and processes, designed and manufactured in the identical facility, and are characterized by the identical fundamental product technology as the predicate device (K172225). The indications for use of the proposed device are similar to those of the predicate device (K172225) but differ in that they reference the proposed device's compatibility with the MIS Conical Connection Implants (while the predicate device (K172225) indications reference compatibility with MIS Internal Hex Implants). The proposed indications for use also include the indications for the ATLANTIS Healing Abutments intended as compatible with the MIS Conical Connection Implants in this premarket notification. Geometric compatibility analysis and bench testing have been included in support of substantial equivalence with respect to these differences in the proposed indications for use compared to the cleared indications for use of the predicate device (K172225).
Table 5.3 compares the proposed devices [ATLANTIS® Abutment, ATLANTIS® Crown Abutment, and ATLANTIS® Conus Abutment (Custom or Overdenture)]. Table 5.4 compares the proposed ATLANTIS® Healing Abutment with the reference device, K163349, V3 Conical Connection Healing Caps.
8
| Table 5.3 - Substantial Equivalence Comparison Summary (ATLANTIS Abutments, ATLANTIS Conus Abutments, ATLANTIS
| Crown Abutments | |||||
|---|---|---|---|---|---|
| ATLANTIS® Abutment for MIS Conical Connection | |||||
| Implant | |||||
| Proposed device | ATLANTIS® Abutment for MIS Implant | ||||
| K172225 | |||||
| Predicate Device | |||||
| 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® 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® 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. | 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. | |||||
| The ATLANTIS® Healing Abutment can be used with an | |||||
| endosseous implant for temporary use during soft tissue healing | |||||
| after one-stage or two-stage surgeries. The abutment screw is | |||||
| intended to secure the ATLANTIS® Healing 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 | |||||
| ATLANTIS® Abutment is compatible with MIS Conical | |||||
| Connection implant from MIS Implant System. | table below: | ||||
| Implant manufacturer : MIS IMPLANT TECHNOLOGIES LTD | |||||
| ATLANTIS® products are compatible with the implants shown | |||||
| in the table below: | |||||
| Implant manufacturer : MIS IMPLANT TECHNOLOGIES LTD | |||||
| Trade Name | Abutment Platform | ||||
| Diameter | Implant Diameter | Trade Name | Abutment Platform | ||
| Diameter | Implant Diameter | ||||
| Atlantis Abutment for MIS | |||||
| V3 NP | Ø2.765mm | V3: Ø3.30mm | MIS Implant M4 & | ||
| SEVEN Narrow | |||||
| Platform | Ø3.30 mm | Ø3.30 mm | |||
| Atlantis Abutment for MIS | |||||
| C1 NP | Ø2.76mm | C1: Ø3.30mm | |||
| Atlantis Abutment for MIS | |||||
| C1 & V3 SP | Ø3.16mm | C1: Ø3.75, 4.2 mm, | |||
| V3: Ø3.90, 4.3, 5.0 mm | MIS Implant M4 & | ||||
| SEVEN Standard | |||||
| Platform | Ø3.75 and | ||||
| 4.2 mm | Ø3.75 and 4.2 mm | ||||
| Atlantis Abutment for MIS | |||||
| C1 WP | Ø4.01mm | C1: Ø5.0 mm | MIS Implant M4 & | ||
| SEVEN Wide | |||||
| Platform | Ø5.0 and | ||||
| 6.0 mm | Ø5.0 and 6.0 mm |
9
| | Table 5.3 – Substantial Equivalence Comparison Summary (ATLANTIS Abutments, ATLANTIS Conus Abutments, ATLANTIS
Crown Abutments (continued). | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| | ATLANTIS® Abutment for MIS Conical
Connection Implant
Proposed device | ATLANTIS® Abutment for MIS Implant
K172225
Predicate Device |
| Prosthesis
attachment | Screw-retained
Cement-retained
Friction Fit | Screw-retained
Cement-retained
Friction Fit |
| Restoration | Single or Multi-unit | Single or Multi-unit |
| Abutment
platform
diameter | Ø2.765, 2.76, 3.16, 4.01 mm | Ø 3.3, 3.75, 4.2, 5.0, 6.0 mm |
| Abutment
Angle | Straight, up to 30° | Straight, up to 30° |
| Max.
Abutment
Height | 15 mm | 15 mm |
| Min.
Abutment
Post Height | 4 mm | 4 mm |
| Design
type | Patient specific design | Patient specific design |
| Implant
Connection | Conical Connection | Internal hex connection |
| Material:
Abutment | Titanium alloy, Gold Shaded Titanium (Gold Hue)
[conforming to ASTM F136] | - Titanium alloy, Gold Shaded Titanium (Gold Hue),
[conforming to ASTM F136]
- Zirconia |
| Material:
Screw | Titanium alloy
[conforming to ASTM F136] | Titanium alloy
[conforming to ASTM F136] |
10
| Table 5.4-Difference and Similarities of proposed, predicate and reference devices (Healing Abutments) | |||||
|---|---|---|---|---|---|
| Trade Name | ATLANTIS® Abutment for MIS Conical | ||||
| Connection Implant Healing Abutment | |||||
| Proposed Device | V3 Conical Connection Healing Caps | ||||
| K163349 | |||||
| Reference Device | |||||
| Material(s) | Titanium alloy, Gold Shaded Titanium (Gold Hue) | Titanium 6Al-4V ELI per ASTM F136 | |||
| Interface Diameter | Ø2.76, 2.765, 3.16, 4.01 mm | Cover screws: 2.77,3.15 mm | |||
| Healing caps: 3.3,3.9,4.0,4.8,5.8 mm | |||||
| Gingival height - | |||||
| healing caps | 0.5mm to 4mm (above the margin) | 2,3,4,5,6,8 | |||
| Surface Treatment/ | N/A | Polished and anodized after machined | |||
| Connection Type | Conical Connection | Conical connection | |||
| without indexes | |||||
| Platform | NP/SP/WP | NP/SP | |||
| Sterilization Method | Steam sterilized by end user | Radiation |
7. Non-Clinical Performance Data
Non-clinical testing data submitted, referenced or relied upon to demonstrate substantial equivalence includes:
- Fatigue testing was conducted according to ISO 14801: Dental-implants Dynamic Fatigue Test for . Endosseous Dental Implants. Fatigue test results were compared to the predicate and reference devices.
- Geometric compatibility analysis was conducted on OEM implant bodies, OEM abutments, and ● OEM screws to support the dimensional compatibility of the ATLANTIS® Abutment for MIS Conical Connection Implant with the MIS V3 implants (Narrow: Ø3.3mm and Standard: Ø3.9, 4.3, 5.0mm) and MIS C1 implants (Narrow Ø3.3mm, Standard: Ø3.75, 4.2mm and Wide: Ø5.0, 6.0 mm).
- Sterilization validation of the proposed device is referenced by equivalency to the sterilization validation of predicate (K172225). Predicate device was 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.
- The material composition and manufacturing processing methods of the proposed ATLANTIS® Abutment for MIS Conical Connection Implant are identical to the predicate device, ATLANTIS® Abutment for MIS Implant (K172225). Therefore, no additional biocompatibility data is included to support substantial equivalence.
11
Clinical Performance Data 8.
No human clinical data was included in this premarket notification to support substantial equivalence of the proposed modification to predicate device ATLANTIS® Abutment for MIS Implant (K172225).
9 Conclusion Regarding Substantial Equivalence
The proposed ATLANTIS® Abutments for MIS Conical Connection Implant are endosseous dental implant abutments which are intended to support a prosthetic device in partially or completely edentulous patients. The proposed ATLANTIS® Abutment for MIS Conical Connection Implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate device ATLANTIS® Abutment for MIS Implant (K172225). The proposed device fatigue testing results are substantially equivalent to those of the ATLANTIS® Abutment for HIOSSEN ET Implant (K160626) and therefore this predicate was included as a reference device. The proposed healing abutments are also technologically substantially equivalent to those of the V3 Conical Connection Healing Caps (K163349) and therefore this predicate was also included as a reference device.
In addition, the proposed ATLANTIS® Abutments are compatible with the following implant systems: MIS C1 Narrow Platform Conical Connection Implant System (K172505), MIS C1 Standard and Wide Platform Conical Connection Abutment (K112162), MIS V3 Conical Connection Dental Implant System (K163349). Non-clinical bench testing has been conducted and are included in this premarket notification to demonstrate the performance of the proposed ATLANTIS® Abutments for MIS Conical Connection Implant in support of substantial equivalence. The comparison of the indications for use, technological characteristics, with the inclusion of the results of nonclinical testing, support a conclusion of substantial equivalence of the proposed ATLANTIS® Abutments for MIS Conical Connection Implant to the predicate devices.