(784 days)
No
The summary describes dental prosthetics and their manufacturing process using CAD/CAM technology and validated milling centers. There is no mention of AI or ML being used in the design, manufacturing, or function of the device itself. The performance studies focus on mechanical and biological testing, not algorithmic performance.
Yes
The device is a dental prosthetic designed to support dental restorations, which falls under the definition of a therapeutic device as it is used to treat missing teeth by providing a functional replacement.
No
The device is described as dental prosthetics (base abutments and adhesive sleeves) for supporting dental prosthetic restorations. Its function is to provide physical support for restorations, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium alloy and zirconia, which are dental prosthetics. While CAD/CAM design is mentioned, the core device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "dental prosthetic" placed onto a dental implant or screw retained abutment to support dental prosthetic restorations. This describes a device used in vivo (within the body) for structural support, not a device used in vitro (outside the body) to examine specimens from the human body.
- Device Description: The description details the materials and function of the abutments and sleeves as components of a dental restoration system. It focuses on their mechanical properties and how they connect to implants and other prosthetic parts.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. The device's function is purely mechanical and structural within the oral cavity.
The mentions of "intra-oral scanning" and "digitally designed abutments" relate to the process of creating the custom prosthetic, not to any diagnostic testing. The performance studies focus on mechanical properties, biocompatibility, and safety in an MRI environment, which are typical for implantable or prosthetic devices, not IVDs.
N/A
Intended Use / Indications for Use
AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are dental prosthetics placed onto a dental implant or screw retained abutment, to provide support for dental prosthetic restorations. The Base Abutments and Adhesive Sleeves include: Titanium bases/sleeves with a pre-machined implant connection or screw retained abutment connection on which the CAD/CAM designed upper structure may be fitted to complete a two-piece dental abutment. The Base Abutments and Adhesive Sleeves include an abutment/sleeve screw for fixation to the underlying implant/screw retained abutment. These dental prosthetics may be used for single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with AB Dental Implants with internal connection and screw retained connections for standard and narrow platforms.
All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
A.B. Dental Devices® CADCAM Products consists of; Base Abutments and Adhesive Sleeves which are used with Standard Platform (Internal Hex connection) implants, Narrow Platform implants and Screw retained (P64 and P14/P16 MultiUnit) abutments.
Base Abutments (standard or narrow platform) and Adhesive Sleeves (screw retained abutment platform) are prefabricated abutments/sleeves made to be used as final abutments/ sleeves that will be used as adhesive connection (cement retained) of the prosthetic restoration on implant platform or on Multiunit platforms.
The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral scanning using the manufacturing. All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.
This submission adds the following Base Abutments and Adhesive sleeves:
| Device | Description |
|---|---|
| Ti Base Anti-Rotational Abutments (Standard or Narrow platforms) | Base Abutment |
| Ti Base Rotational Abutments (Standard or Narrow platforms) | Base Abutment |
| P64 Ti Conical Adhesive Sleeve | Adhesive Sleeve |
| Ti Straight Adhesive Sleeves | Adhesive Sleeve |
Base Abutments;
The titanium bases are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
Adhesive Sleeves
The adhesive sleeves are all Rotational (non-engage) for bridges restoration.
The adhesive sleeves are made of Titanium alloy (Ti-6Al-4V ELI) and will be installed on straight or angular screw-retained abutments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted to demonstrate substantial equivalence included:
-
Engineering analysis to determine if additional components constitute a new mechanical worst-case. .
-
Cytotoxicity testing per ISO 10993-5 (Nelson Lab. Study Number 1502319-S01).
-
Fatigue testing at 40° per ISO 14801 on the two worst case constructs of the subject submission.
-
Sterilization validation according to ANSI/AAMI/ISO 17665 (Sterilization of health care products- Moist heat- Part 1 and 2, ISO 11138- Sterilization of health care products- Biological indicators – Part 1, 3 and 7)
-
The conducted MRI testing conducted per standards listed hereunder demonstrates that the claimed products are MR Conditional:
- ASTM F2052-21 (Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2213-17 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2182-19 (Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging)
-
ASTM F2119-2013 (Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants) A patient with this device can be scanned safely in an MR system under the conditions as stated in the labeling (Recommended MRI labeling based on the document; American Society of Testing and Materials, International, ASTM F2503-20. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR)
Environment, Guidance for Industry and Food and Drug Administration Staff, Document issued on May 20, 2021.) No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
A.B. Dental Device Ltd. % Nissim Shaked RA Specialist Nissim Shaked RA Specialist 17th Tel-Hay St. Raanana, 4340525 ISRAEL
Re: K202144
Trade/Device Name: A.B. Dental Devices® Dental Implants System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 1, 2022 Received: August 23, 2022
Dear Nissim Shaked:
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.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K202144
Device Name
A.B. Dental Devices® Dental Implants System
Indications for Use (Describe)
AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are dental prosthetics placed onto a dental implant or screw retained abutment, to provide support for dental prosthetic restorations. The Base Abutments and Adhesive Sleeves include: Titanium bases/sleeves with a pre-machined implant connection or screw retained abutment connection on which the CAD/CAM designed upper structure may be fitted to complete a two-piece dental abutment. The Base Abutments and Adhesive Sleeves include an abutment/sleeve screw for fixation to the underlying implant/screw retained abutment. These dental prosthetics may be used for single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with AB Dental Implants with internal connection and screw retained connections for standard and narrow platforms.
All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.
| 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.
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3
510(K) SUMMARY A.B. Dental Devices® CADCAM Products
Sponsor:
A.B. Dental Devices Ltd. 19 Hayalomim St., Ashdod 7761117 Israel
Contact Person: Gabi Krauss
RA Manager Phone: 972-8-8531388 Facsimile: 972-8-8522562
| Date Prepared: | September 22, 2022 |
|---|---|
| Name of Device: | A.B. Dental Devices® Dental Implants System |
| Common or Usual Name: | Base Abutment/ Adhesive sleeve |
| Classification Name: | Endosseous dental implant abutment; 21 CFR §872.3630 |
| Product Code: | NHA |
Class II
Predicate Devices:
Regulatory Class:
K181580 Cortex CAD/CAM Abutments
Device Description
A.B. Dental Devices® CADCAM Products consists of; Base Abutments and Adhesive Sleeves which are used with Standard Platform (Internal Hex connection) implants, Narrow Platform implants and Screw retained (P64 and P14/P16 MultiUnit) abutments.
Base Abutments (standard or narrow platform) and Adhesive Sleeves (screw retained abutment platform) are prefabricated abutments/sleeves made to be used as final abutments/ sleeves that will be used as adhesive connection (cement retained) of the prosthetic restoration on implant platform or on Multiunit platforms.
The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral scanning using the manufacturing. All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.
This submission adds the following Base Abutments and Adhesive sleeves:
| Device | Description |
|---|---|
| Ti Base Anti-Rotational Abutments (Standard or Narrow platforms) | Base Abutment |
| Ti Base Rotational Abutments (Standard or Narrow platforms) | Base Abutment |
| P64 Ti Conical Adhesive Sleeve | Adhesive Sleeve |
| Ti Straight Adhesive Sleeves | Adhesive Sleeve |
Base Abutments;
The titanium bases are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
-
Raw material Zirconium blanks
Dental Direkt Zirconia Blanks by Dental Direkt GmbH, cleared under K183569 -
Dental Cement
PANAVIA SA Cement Universal by Kuraray Noritake Dental Inc., cleared under K183537
4
510(K) Summary Page 2 of 5
Zirconia structure Details
| Spec. | Zirconium Blank | |
|---|---|---|
| Trade name | Dental Direkt Zirconia Blanks | |
| Common name | Dental zirconia blanks/blocks | |
| Manufacturer | Dental Direkt GmbH | |
| 510K number | K183569 | |
| Product code | EIH | |
| Regulatory class | Class II | |
| Intended use | DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges. |
Adhesive Sleeves
The adhesive sleeves are all Rotational (non-engage) for bridges restoration.
The adhesive sleeves are made of Titanium alloy (Ti-6Al-4V ELI) and will be installed on straight or angular screw-retained abutments.
The Multiunit (screw retained abutments already cleared devices) are P14/P16 platform: The below listed devices are previously cleared items that the sleeves are intended to be used with:
| Ref No. |
|---|
| P14-3,17-1 |
| P14-3,17-3 |
| P14-3,30-1 |
| P14-3,30-3 |
| P14-3.75,17-1 |
| P14-3.75,17-3 |
| P14-3.75,30-1 |
| P14-3.75,30-3 |
| P16-3.75,1 |
| P16-3.75,2 |
| P16-3.75,3 |
| P16-3.75,4 |
| P16-3.75,5 |
| P64-3,1 |
| P64-3,17-0.5 |
| P64-3,17-2 |
| P64-3,2 |
| P64-3,3 |
| P64-3,30-0.5 |
| P64-3,30-2 |
| P64-3.75,1 |
| P64-3.75,2 |
| P64-3.75,3 |
| P64-3.75,4 |
| P64-3.75,5 |
| P64-3.75,17-0.5 |
| P64-3.75,17-2 |
| P64-3.75,17-3 |
| P64-3.75,30-0.5 |
| P64-3.75,30-2 |
| P64-3.75.30-3 |
Indications for Use
AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are dental prosthetics placed onto a dental implant or screw retained abutment, to provide support for dental prosthetic restorations. The Base Abutments and Adhesive Sleeves include: Titanium bases/sleeves with a pre-machined implant connection or screw retained abutment connection on which the CAD/CAM designed upper structure may be fitted to complete a two-piece dental abutment. The Base Abutments and Adhesive Sleeves include an abutment/sleeve screw for fixation to the underlying implant/screw retained abutment.
5
510(K) Summary Page 3 of 5
These dental prosthetics may be used for single-unit (bingle-unit (bridges and bars) restorations and are compatible for use with AB Dental Implants with internal connection and screw retained connections for standard and narrow platforms.
All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.
Technological Characteristics Comparison
| Subject Device | Predicate | |
|---|---|---|
| Device Name | Base Abutment/ Adhesive Sleeves | Ti-Base Abutment 2-CONnect Abutment |
| 510(k) number | K202144 | K181580 |
| Manufacture | A.B. Dental Devices Ltd. | Cortex Dental Implants Industries Ltd. |
| Classification | 872.3630 | 872.3630 |
| Indications for | ||
| Use | AB Dental CAD/CAM Base Abutments and | |
| Adhesive Sleeves are dental prosthetics placed | ||
| onto a dental implant or screw retained | ||
| abutment, to provide support for dental | ||
| prosthetic restorations. The Base Abutments | ||
| and Adhesive Sleeves include: Titanium | ||
| bases/sleeves with a pre-machined implant | ||
| connection or screw retained abutment | ||
| connection on which the CAD/CAM designed | ||
| upper structure may be fitted to complete a | ||
| two-piece dental abutment. The Base | ||
| Abutments and Adhesive Sleeves include an | ||
| abutment/sleeve screw for fixation to the | ||
| underlying implant/screw retained abutment. | ||
| These dental prosthetics may be used for single- | ||
| unit (single-tooth) or multiple-unit (bridges and | ||
| bars) restorations and are compatible for use | ||
| with AB Dental Implants with internal | ||
| connection and screw retained connections for | ||
| standard and narrow platforms. | ||
| All digitally designed abutments and/or copings | ||
| for use with AB Dental CAD/CAM Base | ||
| Abutments and Adhesive Sleeves are intended | ||
| to be sent to AB Dental validated milling center | ||
| for manufacture. | Cortex CAD/CAM Abutments are dental | |
| abutments placed onto a dental implant to | ||
| provide support for dental prosthetic | ||
| restorations. The abutments include: 1) Titanium | ||
| abutment blanks with a pre-machined implant | ||
| connection where the upper portion may be | ||
| custom- milled in accordance with a patient- | ||
| specific design using CAD/CAM techniques; and |
- Titanium bases with a pre-machined implant
connection upon which a CAD/CAM designed
superstructure may be fitted to complete a two-
piece dental abutment. The abutments include
an abutment screw for fixation to the underlying
implant. The abutments may be used for single-
unit (single-tooth) or multiple-unit (bridges and
bars) restorations and are compatible for use
with Cortex Dental Implants with internal hex-
connection mating platform and conical
connection platform diameters.
All digitally designed abutments and/or copings
for use with Cortex CAD/CAM Abutments are
intended to be sent to a Cortex-validated milling
center for manufacture. Cortex abutments
designed using CAD/CAM techniques must fulfill
the Cortex allowable range of design parameters. |
The indications for the subject device and the indications cleared in K181580 are provided above.
The difference between the subject device and the predicate is that the highlighted sections were removed as this submission doesn't include the Titanium abutment blanks.
In addition, in the predicate devices the description of the Ti-Base refers also to screw retained sleeves (they refer to them as abutment or 2-component abutment).
The language was also adjusted to match AB Dental products throughout the text.
The sleeves are intended to be used with devices that are angled at 0°, 17°, and 30°. No additional angulation provided by these sleeves or the CAD/CAM ceramic restorations.
The purpose of this traditional 510(k) is to expand the current product line to include the new abutments listed below. No substantive changes are being made to the indications. Comparison tables for each modification are provided below.
1. Anti-Rotational Base Abutments (P3,TI)
| Spec. | Subject P3-X,TI,XX ; P3H-X,TIT; (X=3.75
or 3) (XX=Different Lengths) | Predicate
CORTEX |
|-------------|-------------------------------------------------------------------------|---------------------|
| 510k number | K202144 | K181580 |
6
| Spec. | Subject P3-X,TI,XX ; P3H-X,TIT; (X=3.75
or 3) (XX=Different Lengths) | Predicate
CORTEX |
|----------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Diagram | Image: dental implant | Image: dental implant |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Platform
(Internal implant
connection) | Standard Platform,
Narrow platform | Internal Hex,
Conical Connection |
| Diameter, mm | 4.3, 5.2
4.3, 5.2 | 5.2 |
| Overall Length, mm | 6.45 ,7.85 ,8.85, 7.05
6.8, 8.0, 9.0, 7.3 | Internal Hex
Collar Height:1, 3 Body Height: 4
Conical Connection
Collar Height:1, 2, 3 Body Height: 4 |
| Angulation | Minimum and Maximum abutment
angle (°): Straight structure with 0°
angle | Minimum and Maximum abutment angle (°):
Straight structure with 0° angle |
| Design | Anti-rotation | Anti-rotation |
| Zirconia | FDA Cleared Zirconia
To be manufactured by validated milling
center | FDA Cleared Zirconia
To be manufactured by validated milling center |
| Sterility | End user sterilized | End user sterilized |
Rotational Base Abutment (P3, TIT) 2.
| Spec. | Subject P3N-X,TIT,XX ; P3-X,TIT;
(X=3.75 or 3) (XX=Different Lengths) | Predicate
CORTEX |
|----------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Picture | Image: Subject | Image: Cortex |
| 510k number | Subject | K181580 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Platform
(Internal implant
connection) | Standard Platform,
Narrow platform | Internal Hex,
Conical Connection |
| Diameter, mm | 4.3, 5.2
4.1, 5.2 | 4.6 |
| Overall Length, mm | 6.85 ,7.29 ,8.29, 6.85 | Internal Hex
Collar Height:1, 3 Body Height: 4
Conical Connection
Collar Height:1, 2, 3 Body Height: 4 |
| Angulation | Minimum and Maximum abutment
angle (°): Straight structure with 0°
angle | Minimum and Maximum abutment angle (°):
Straight structure with 0° angle |
| Design | Rotational (Non engaging) | Rotational (Non engaging) |
| Zirconia | FDA Cleared Zirconia
To be manufactured by validated
milling center | FDA Cleared Zirconia
To be manufactured by validated milling center |
| Sterility | End user sterilized | End user sterilized |
7
3. Adhesive Sleeves - Cement Retained, Non-Angled Sleeves (P64, P14)
| Spec. | Subject: P64 and P14 Adhesive Sleeves | Predicate CORTEX (refer Multi Unit Ti-Base) |
|---|---|---|
| Diagram | Image: (P14-bTs) | |
| Image: (P64-bTs-C) | Image: Diagram of body and collar height | |
| Image: Two Cortex sleeves | ||
| 510k number | Subject | K181580 |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Platform | ||
| (screw retained | ||
| connection) | P64 | |
| P14 | Multiunit | |
| 2-CONnect | ||
| Diameter, mm | 4.9 | |
| 4.4 | 5 | |
| Length, mm | 5.5 | Collar Height:0.3, 0.7 |
| Body Height: 4 | ||
| Design | Sleeve | Sleeve |
| Sterility | End user sterilized | End user sterilized |
Performance Data
Non-clinical data submitted to demonstrate substantial equivalence included:
-
Engineering analysis to determine if additional components constitute a new mechanical worst-case. .
-
Cytotoxicity testing per ISO 10993-5 (Nelson Lab. Study Number 1502319-S01). ●
-
. Fatigue testing at 40° per ISO 14801 on the two worst case constructs of the subject submission.
-
. Sterilization validation according to ANSI/AAMI/ISO 17665 (Sterilization of health care products- Moist heat- Part 1 and 2, ISO 11138- Sterilization of health care products- Biological indicators – Part 1, 3 and 7)
-
. The conducted MRI testing conducted per standards listed hereunder demonstrates that the claimed products are MR Conditional:
- ASTM F2052-21 (Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2213-17 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2182-19 (Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging)
-
ASTM F2119-2013 (Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants) A patient with this device can be scanned safely in an MR system under the conditions as stated in the labeling (Recommended MRI labeling based on the document; American Society of Testing and Materials, International, ASTM F2503-20. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR)
Environment, Guidance for Industry and Food and Drug Administration Staff, Document issued on May 20, 2021.) No clinical data were included in this submission.
Conclusions
Based on the data included in this submission, A.B. Dental Implants System is substantially equivalent in indication and design principles to the predicate device indicated above.