(175 days)
Not Found
No
The summary describes conventional and CAD-CAM dental abutments and their materials and compatibility. There is no mention of AI or ML technology being used in the design, manufacturing process, or function of the device. The "digitally designed" aspect refers to CAD-CAM, which is a standard digital design and manufacturing process, not necessarily involving AI/ML.
Yes
The device is described as "supporting single-unit or multi-unit prosthetic restorations" in conjunction with dental implants, which implies a therapeutic function by restoring dental function and aesthetics.
No
The device, AccelX™ Abutments, is intended to provide support for prosthetic restorations of dental implants, which is a supportive and restorative function, not a diagnostic one.
No
The device description explicitly states that the device comprises conventional and CAD-CAM abutments, abutment screws, and other associated components, which are physical hardware. While it mentions digitally designed abutments being sent for manufacture, the core device being cleared is the physical abutment system.
Based on the provided text, the AccelX™ Abutments device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing support for dental prosthetic restorations in the mouth. This is a direct medical intervention on a patient.
- Device Description: The description details the materials and types of abutments used in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, the AccelX™ Abutments are a medical device used in dental procedures, not an in vitro diagnostic device.
N/A
# Intended Use / Indications for Use
AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components as listed below.
# Product codes
NHA
# Device Description
AccelX™ Abutments comprises conventional and CAD-CAM abutments, abutment screws, and other associated components compatible with MegaGen AnyRidge Internal Implant System.
AccelX™ conventional abutments and prosthetic components include Cover Screws. Healing Abutments. Temporary Abutments, Prepable Straight Abutments, Angled Abutments, Castable Base Abutments, and Multi-Unit Abutments. All conventional abutments and prosthetic components are manufactured from Ti-Al-4V alloy conforming to ASTM F136 except the Castable Base Abutments that are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.
AccelX™ CAD-CAM abutments include Titanium Base Abutments for use with a zirconia coping, and Titanium Blank Abutments to be milled to a final one-piece abutment. Titanium Base Abutments are two-piece abutments composed of the titanium base component and a zirconia top-half, which comprises the final abutment once the two components are cemented together using CemPlant Implant Cement. The Titanium Base Abutments and Titanium Blank Abutments are manufactured from Ti-Al-4V alloy conforming to ASTM F136. The zirconia copings for the Titanium Base Abutments will be manufactured from zirconia conforming to ISO 13356. All digitally designed abutments for use with AccelX™ CAD-CAM abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
maxillary or mandibular arch
# 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)
The subject device was evaluated and tested as recommended in the FDA guidance documents Root Form Endosseous Dental Implants and Endosseous Dental Implant Abutments (issued May 12, 2004), and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020).
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: moist heat (steam) sterilization according to ISO 17665-1, and ISO 17665-2 (included in this submission and referenced from [K140728](https://510k.innolitics.com/search/K140728) and [K191986](https://510k.innolitics.com/search/K191986)); biocompatibility data for the ASTM F136 titanium alloy (included in this submission and referenced from [K191986](https://510k.innolitics.com/search/K191986)), for the ASTM F1537 Co-Cr-Mo alloy (referenced from [K191986](https://510k.innolitics.com/search/K191986)), and included in this submission for the ISO 13356 zirconia material used to fabricate copings for Titanium Base Abutments. Testing to demonstrate compatibility to the OEM system included reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws, and static compression and compression fatigue testing according to ISO 14801.
No clinical data were included in this submission.
The fatigue limit data demonstrated that constructs of the subject device abutments, including abutments fabricated to the limits stated in the proposed labeling, in combination with previously-cleared MegaGen AnyRidge Internal Implant System implants have sufficient strength for their intended use.
# 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.
[K191986](https://510k.innolitics.com/search/K191986), [K123988](https://510k.innolitics.com/search/K123988), [K182448](https://510k.innolitics.com/search/K182448), [K140091](https://510k.innolitics.com/search/K140091), [K140728](https://510k.innolitics.com/search/K140728)
# 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.
Not Found
# 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
Integrated Dental Systems LLC % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K203240
Trade/Device Name: AccelXTM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 29, 2021 Received: March 29, 2021
Dear Kevin Thomas:
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203240
Device Name
AccelXTM Abutments
Indications for Use (Describe)
AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components as listed below.
| Implant System Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| MegaGen AnyRidge Internal | ||
| Implant System | 4.0 | 3.5 |
| 4.4 | 3.5 | |
| 4.9 | 3.5 | |
| 5.4 | 3.5 | |
| 5.9 | 3.5 | |
| 6.4 | 5.0 | |
| 6.9 | 5.0 | |
| 7.4 | 5.0 | |
| 7.9 | 5.0 | |
| 8.4 | 5.0 |
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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510(k) Summary K203240 AccelX™ Abutments Integrated Dental Systems, LLC
April 27, 2021
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Integrated Dental Systems, LLC
145 Cedar Lane
Englewood, New Jersey 07631 | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|
| | Telephone | +1 917-693-5595 | |
| Official Contact | David Singh, Chief Operating Officer | | |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 | | |
| | Telephone | +1 858-792-1235 | |
| | Fax | +1 858-792-1236 | |
| | Email | kthomas@paxmed.com
flarson@paxmed.com | |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | AccelX™ Abutments |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Health Technology 1 B (Dental Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K191986, DESS Dental Smart Solutions, Terrats Medical SL Additional Predicate Devices K123988, AnyOne™ Internal Implant System, MegaGen Implant Company, Limited K182448, AnyRidge Octa 1 Implant System, MegaGen Implant Co., Ltd. K140091, Xpeed AnyRidge Internal Implant System, MegaGen Implant Co., Ltd. K140728, Dental Implants and Abutments, Ditron Precision Ltd.
4
K191986 is the primary predicate for support of substantial equivalence in terms of Indications for Use, CAD-CAM abutments, and referenced sterilization and biocompatibility data. The additional predicates K123988 and K182448 are for support of substantial equivalence in terms of component designs. The predicate K140091 is for support of substantial equivalence in terms of the OEM compatibilities. The additional predicate K140728 is for referenced sterilization and biocompatibility data.
INDICATIONS FOR USE STATEMENT
AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components as listed below.
| Implant System Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| MegaGen AnyRidge Internal | ||
| Implant System | 4.0 | 3.5 |
| 4.4 | 3.5 | |
| 4.9 | 3.5 | |
| 5.4 | 3.5 | |
| 5.9 | 3.5 | |
| 6.4 | 5.0 | |
| 6.9 | 5.0 | |
| 7.4 | 5.0 | |
| 7.9 | 5.0 | |
| 8.4 | 5.0 |
SUBJECT DEVICE DESCRIPTION
AccelX™ Abutments comprises conventional and CAD-CAM abutments, abutment screws, and other associated components compatible with MegaGen AnyRidge Internal Implant System.
AccelX™ conventional abutments and prosthetic components include Cover Screws. Healing Abutments. Temporary Abutments, Prepable Straight Abutments, Angled Abutments, Castable Base Abutments, and Multi-Unit Abutments. All conventional abutments and prosthetic components are manufactured from Ti-Al-4V alloy conforming to ASTM F136 except the Castable Base Abutments that are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.
AccelX™ CAD-CAM abutments include Titanium Base Abutments for use with a zirconia coping, and Titanium Blank Abutments to be milled to a final one-piece abutment. Titanium Base Abutments are twopiece abutments composed of the titanium base component and a zirconia top-half, which comprises the final abutment once the two components are cemented together using CemPlant Implant Cement. The Titanium Base Abutments and Titanium Blank Abutments are manufactured from Ti-Al-4V alloy conforming to ASTM F136. The zirconia copings for the Titanium Base Abutments will be manufactured
5
from zirconia conforming to ISO 13356. All digitally designed abutments for use with AccelX™ CAD-CAM abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture. The AccelX™ abutments and prosthetic components are summarized in the following table.
| Coronal Ø, mm | Angle | Material | |
|---|---|---|---|
| Cover Screws | 3.5 | n/a | Titanium alloy, ASTM F136 |
| Healing Abutments | 4, 5, 6, 7, 8, 10 | n/a | Titanium alloy, ASTM F136 |
| Prosthetic Platform Ø, mm | |||
| Temporary Abutments | 4 | n/a | Titanium alloy, ASTM F136 |
| Prepable Straight Abutments | 4, 5, 6, 7; | ||
| 4.5, 5.5, 6.5 | n/a | Titanium alloy, ASTM F136 | |
| Angled Abutments | 4, 5, 6, 7 | 15°, 25° | Titanium alloy, ASTM F136 |
| Castable Base Abutment - Co-Cr-Mo Alloy | 3.8 | 0° | Co-Cr-Mo alloy, ASTM F1537 |
| Multi-Unit Abutments | 4.8 | 0°, 17°, 30° | Titanium alloy, ASTM F136 |
| Titanium Base Abutments | 4.0, 4.4 | 0° (coping) | Titanium alloy, ASTM F136 |
| Zirconia, ISO 13356 | |||
| Titanium Blank Abutments | 6.9 (or per available space) | Up to 30° | Titanium alloy, ASTM F136 |
| Abutment Multi Post Screw | |||
| Multi-Unit Abutment Screw | |||
| Multi-Unit Prosthetic Screw | n/a | n/a | Titanium alloy, ASTM F136 |
The subject device abutments and healing components are compatible with MegaGen AnyRidge Internal System components (K140091).
PERFORMANCE DATA
The subject device was evaluated and tested as recommended in the FDA guidance documents Root Form Endosseous Dental Implants and Endosseous Dental Implant Abutments (issued May 12, 2004), and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020).
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: moist heat (steam) sterilization according to ISO 17665-1, and ISO 17665-2 (included in this submission and referenced from K140728 and K191986); biocompatibility data for the ASTM F136 titanium alloy (included in this submission and referenced from K191986), for the ASTM F1537 Co-Cr-Mo alloy (referenced from K191986), and included in this submission for the ISO 13356 zirconia material used to fabricate copings for Titanium Base Abutments. Testing to demonstrate compatibility to the OEM system included reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws, and static compression and compression fatigue testing according to ISO 14801.
No clinical data were included in this submission.
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EQUIVALENCE TO MARKETED DEVICES
The subject devices are substantially equivalent in indications and design principles to the primary predicate device and the additional predicate devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and a table comparing the technological characteristics of the subject device, the primary predicate device, and the additional predicate devices.
The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate K191986 and to the additional predicate devices. Slight differences in the language of the IFUS do not affect the intended use as dental implant abutments for support of a prosthesis to restore chewing function.
Minor differences between the IFUS for the subject device and the primary predicate device K191986 include differences in tradenames, differences in validated milling centers, differences in the compatible OEM implant systems, and K191986 is limited to abutments for CAD-CAM technology. These minor differences do not raise new questions of safety or effectiveness because both IFUS express equivalent intended use.
Minor differences between the IFUS for the subject device and the additional predicate devices K123988. K182448, and K140091 include: the subject device IFUS includes the term "single-unit or multi-unit prosthetic restorations" and the predicate devices use alternative terminology "Crown, bridges, and overdentures": the subject device IFUS includes references to CAD-CAM technology to fabricate patientspecific abutments, validated milling centers, and compatible OEM implant systems and the additional predicate IFUS does not include these elements; and differences in tradenames. These minor differences do not raise new questions of safety or effectiveness because all IFUS express equivalent intended use.
Subject Device Abutments
The following subject device designs are substantially equivalent to the predicate device K123988: Cover Screws, Healing Abutments, Temporary Abutments, Prepable Straight Abutments, and Angled Abutments. These subject device prosthetic components and the corresponding predicate device prosthetic components are all manufactured from titanium allov and are compatible with the MegaGen AnyRidge Internal Implant System. The subject device Cover Screws have a coronal diameter 3.5 mm, and provided in cuff heights ranging from 1 mm to 2.8 mm. The predicate device cover screws have a coronal diameter 3.5 mm, and provided in cuff heights ranging from 0.8 mm to 2.6 mm. Both the subject device and predicate device are threaded to match the internal thread of the implant. The subject device Healing Abutments and the predicate device healing abutments have a coronal diameter ranging from 4 mm to 10 mm, cuff heights ranging from 3 mm to 7 mm, and are threaded to match the internal thread of the implant. The subject device Temporary Abutments and the predicate device temporary abutments have a 2 mm cuff height, a 4 mm prosthetic platform diameter, and a 10 mm prosthetic post. The subject device Prepable Straight Abutments and the predicate device EZ Post Abutments have a cuff height ranging from 2 mm to 5 mm, prosthetic platform diameters ranging from 4 mm to 7 mm, and a prosthetic post of 5.5 mm or 7 mm. The subject device Angled Abutments and predicate device angled abutments have a cuff height ranging from 2 mm to 5 mm, prosthetic platform diameters ranging from 4 mm to 7 mm, a prosthetic post of 7 mm, and an angle of 15° or 25°.
The subject device Multi-Unit Abutments designs are substantially equivalent to the predicate device K 182248. The subject device and predicate device abutments are for multi-unit restorations, have a
7
prosthetic diameter of 4.8 mm, include angulations of 0°, 17°, and 30°, have an internal implant interface connection, and are manufactured from titanium alloy. The subject device and predicate device abutments with angulation of 0° are provided in cuff heights ranging from 1.3 mm. The subject device abutments with angulation of 17° are provided with cuff heights ranging from 2.5 mm. The subject device abutments with angulation of 30° are provided with cuff heights 3.5 mm and 4.5 mm. The predicate device abutments with angulation of 17° and 30° are provided with cuff heights ranging from 2.3 mm to 4.3 mm. The subject device Multi Unit Abutment Cylinder (coping) is substantially equivalent in material and design to the predicate device cylinder (coping) cleared in K182248.
The subject device Castable Base Abutment – Co Cr Mo Alloy design is substantially equivalent to the predicate device K182248. The subject and predicate device abutments are bases for a final abutment fabricated by the traditional cast-to (lost wax) method with non-precious alloys, without angulation. The subject and predicate devices have a prosthetic diameter of 3.8 mm.
The subject device Titanium Base Abutments designs are substantially equivalent to the predicate K123988. The subject device Titanium Base Abutments have a prosthetic post height of 4.5 mm or 6 mm, with a cut out section in one side of the post to allow for an angled access to the screw channel, and have a cuff height of 0.6 mm or 1.5 mm. The predicate device titanium base abutments have a prosthetic post height of 4.5 mm, 6.0 mm, and 8.0 mm, with a cut out section in one side of the post to allow for an angled access to the screw channel, and have a cuff height of 0.6 mm, 1.5 mm, 3.0 mm, or 4.0 mm. Both the subject device and predicate device titanium base abutments are two-piece abutments composed of a titanium base component and a zirconia top-half, which comprises the final abutment once the two components are cemented together.
The subject device Titanium Blank Abutments are substantially equivalent to the predicate K191986. The overall (milling) diameter of the subject device is 10 mm or 12 mm, and the overall (milling) diameter of the predicate device is 10 mm and 14 mm. Both the subject device and predicate device are manufactured from titanium alloy and are compatible with MegaGen AnyRidge Internal Implant System.
All subject device prosthetic components are provided non-sterile and are to be sterilized to a sterility assurance level (SAL) of 10-6 by the end user using the same sterilization method (moist heat) and parameters for devices previously cleared. Sterilizations for the subject devices were performed according to ISO 17665-1 and ISO TR 17665-2.
The subject device Cover Screws, Healing Abutments, Angled Abutments, Multi Unit Abutments, and Titanium Base Abutments are contract manufactured by Ditron Dental Ltd. for Integrated Dental Systems. The sterilization method and parameters for these subject devices are the same as the predicate device K140728. Therefore, no new sterilization was performed because the subject device components are substantially equivalent to the predicate device K140728.
The subject device Temporary Abutments are contract manufactured by Terrats Medical SL for Integrated Dental Systems. The sterilization method and parameters for the Subject device Temporary Abutments are the same as the predicate device K191986. Therefore, no new sterilization was performed because the subject device components are substantially equivalent to the predicate device K191986.
The subject device Prepable Abutments are contract manufactured by La Precision for Integrated Dental Systems. Sterilization method and parameters were validated according to ISO 17665-1 and ISO TR 17665-2. Similarly, the sterilization method and parameters for subject device Castable Base Abutment –
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Co-Cr-Mo Alloy and Titanium Blank Abutments with zirconia superstructure were validated according to ISO 17665-1 and ISO TR 17665-2.
The subject device prosthetic components were evaluated for biocompatibility or tested according to ANSI/AAMI/ISO 10993-5 and ANSI/AAMI/ISO 10993-12.
The subject device Cover Screws, Healing Abutments, Angled Abutments, Multi Unit Abutments, Multi-Unit Abutment Cylinder, and Titanium Base Abutments are contract manufactured by Ditron Dental Ltd. for Integrated Dental Systems. These subject devices are manufactured from titanium alloy, conforming to ASTM F136, in the same facilities using the same manufacturing processes and same materials as used for Ditron Precision components previously cleared in K140728. Confirmatory biocompatibility testing of the titanium alloy was performed according to ISO 10993-5 and ISO 10993-12.
The subject device Temporary Abutments, Titanium Blank abutments, and Castable Base Abutment -Co-Cr-Mo Alloy are contract manufactured by Terrats Medical SL for Integrated Dental Systems. Temporary Abutments and Titanium Blank Abutments are manufactured from titanium alloy conforming to ASTM F136. The Castable Base Abutment – Co-Cr-Mo Alloy are manufactured from cobalt chromium alloy conforming to ASTM F1537. These subject devices are manufactured from the same materials, in the same facilities using the same manufacturing processes as used for Terrats Medical component previously cleared in K191986. Therefore, no new biocompatibility testing was performed, as the subject device Temporary Abutments. Titanium Blank abutments, and Castable Base Abutment - Co-Cr-Mo Alloy are substantially equivalent to the predicate device K191986 with regards to materials and processing.
The subject device Prepable Abutments are contract manufactured by La Precision for Integrated Dental Systems. Prepable Abutments are manufactured from titanium alloy conforming to ASTM F136. Confirmatory biocompatibility testing was tested according to ANSI/AAMI/ISO 10993-5 and ANSI/AAMI/ISO 10993-12 because these subject devices are not manufactured from the same materials, in the same facilities using the same manufacturing processes as a predicate device.
Additional cytotoxicity testing was conducted on the subject device Titanium Base Abutments with zirconia superstructure.
Mechanical performance testing of the subject device was performed in conformance to ISO 14801. The fatigue limit data demonstrated that constructs of the subject device abutments, including abutments fabricated to the limits stated in the proposed labeling, in combination with previously-cleared MegaGen AnyRidge Internal Implant System implants have sufficient strength for their intended use.
Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines among the subject device, the primary predicate device, and the additional predicate devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing.
CONCLUSION
The subject device, the primary predicate device, the additional predicate devices, and the reference device have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, the additional predicate devices, and the
9
reference device encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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Table of Substantial Equivalence– Indications for Use Statements
| Indications for Use Statement | ||||
|---|---|---|---|---|
| Subject Device | ||||
| K203240 | ||||
| AccelX™ Abutments | ||||
| Integrated Dental Systems LLC | AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support. | |||
| All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated. | ||||
| AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components as listed below. | ||||
| Implant System Compatibility | Implant Body Diameter, mm | Implant Platform, mm | ||
| MegaGen AnyRidge Internal Implant System | 4.0 | 3.5 | ||
| 4.4 | 3.5 | |||
| 4.9 | 3.5 | |||
| 5.4 | 3.5 | |||
| 5.9 | 3.5 | |||
| 6.4 | 5.0 | |||
| 6.9 | 5.0 | |||
| 7.4 | 5.0 | |||
| 7.9 | 5.0 | |||
| 8.4 | 5.0 | |||
| Primary Predicate Device | ||||
| K191986 | ||||
| DESS Dental Smart Solutions | ||||
| Terrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular. | |||
| All digitally designed custom abutments for use with Ti Base abutments or Pre-milled (Blank) abutments are to be sent to a Terrats Medical validated. | ||||
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform | ||
| Ankylos C/X | 3.5, 4.5, 5.5 | 2.52 mm | ||
| 3.6 | 2.9 mm | |||
| Astra Tech EV | 4.2 | 3.5 mm | ||
| 4.8 | 4.1 mm | |||
| 3.0 | 3.0 mm | |||
| Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 mm | ||
| 4.5/5.0 | 4.5/5.0 mm | |||
| 3.25 | 3.45 mm | |||
| Biomet 3i Certain® | 4.0 | 4.1 mm | ||
| 5.0 | 5.0 mm | |||
| 3.25 | 3.4 mm | |||
| Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 mm | ||
| 5.0 | 5.0 mm | |||
| 3.3 | 3.3 mm | |||
| Camlog | 3.8 | 3.8 mm | ||
| 4.3 | 4.3 mm | |||
| 5.0 | 5.0 mm | |||
| 3.4 | 3.4 mm | |||
| 3.8 | 3.8 mm | |||
| FRIADENT XiVE® | 4.5 | 4.5 mm | ||
| 5.5 | 5.5 mm | |||
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 mm | ||
| 3.0 | 3.0 (3.0 mm) | |||
| NobelActive®, | 3.5 | NP (3.5 mm) | ||
| NobelParallel Conical | 4.3, 5.0 | RP (3.9 mm) | ||
| 5.5 | WP (5.1 mm) | |||
| 3.5 | NP (3.5 mm) | |||
| NobelReplace® Trilobe | 4.3 | RP (4.3 mm) | ||
| 5.0 | WP (5.0 mm) | |||
| 6.0 | 6.0 (6.0 mm) | |||
| Indications for Use Statement | ||||
| Nobel Brånemark System® | 3.3 | NP (3.5 mm) | ||
| 3.75, 4.0 | RP (4.1 mm) | |||
| 5.0 | WP (5.1 mm) | |||
| 3.5 | Mini (2.8 mm) | |||
| Osstem TS | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular (3.35 mm) | ||
| Straumann® Bone Level | 3.3 | NC (3.3 mm) | ||
| 4.1/4.8 | RC (4.1/4.8 mm) | |||
| Straumann® Tissue Level | 3.3 | NNC (3.5 mm) | ||
| 3.3, 4.1, 4.8 | RN (4.8 mm) | |||
| 4.8 | WN (6.5 mm) | |||
| Zimmer Screw Vent®/Tapered | ||||
| Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 mm | ||
| 4.7 | 4.5 mm | |||
| 6.0 | 5.7 mm | |||
| Additional Predicate Devices | ||||
| K123988 | ||||
| AnyOne™ Internal Implant System | ||||
| Mega Gen Implant Co., Ltd. | The Any One™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing | |||
| partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for | ||||
| appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading | ||||
| K182448 | ||||
| AnyRidge Octa 1 Implant System | ||||
| Mega Gen Implant Co., Ltd. | The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing p | |||
| partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical proto |
- Delayed loading.
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Larger implants are dedicated for the molar region. | | | |
| K140091
Xpeed AnyRidge Internal Implant System
MegaGenImplantCo.,Ltd. | The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose p
overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm)
and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | | | |
| K140728
DentalImplants and Abutments
Ditron Precision Ltd [Ditron Dental Ltd.] | Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or
order to restore the patient's chewing function.
Two stage: MPI, CPI models
One stage: OPI model
One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible. TI
Two stage and One stage implants for temporary or long-term use: MPI, CPI, OPI are self-tapping titanium threaded screws indicated for long
fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
MPI, CPI and OPI designs are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
MPI, CPI and OPI are indicated for immediate loading in single tooth restorations when good primary stability is achieved with appropriate o
The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration, The 17-degree multi-unit abutme | | | |
pport for single-unit or multi-unit prosthetic restorations. l milling center for manufacture.
arch to provide support for prosthetic restorations. dated milling center for manufacture.
11
Table of Substantial Equivalence– Indications for Use Statements
g prosthetic support for dental restorations (Crown, bridges, and overdentures) in or immediate loading when good primary stability is achieved and with
s thetic support for dental restorations (Crown, bridges, and overdentures) in ols:
oviding prosthetic support for dental restorations (Crown, bridges, and a) are dedicated for immediate loading when good primary stability is achieved
wer jaw to provide support for prosthetic devices, such as artificial teeth, in
ey are also indicated for denture stabilization using multiple implants. erm intra bony applications. They permit immediate splint stability and long-term
clusal loading. ts must be used within 32 degrees of parallelism for a splinted restoration.
12
Table of Substantial Equivalence – Technological Characteristics
| Feature | Subject Device | Primary Predicate Device | Predicate Device | |
|---|---|---|---|---|
| K203240 | K191986 | K123988 | ||
| AccelXTM Abutments | DESS Dental Smart Solutions | AnyOneTM Internal Implant S | ||
| Integrated Dental Systems LLC | Terrats Medical SL | Mega Gen Implant Co. | ||
| Product Code | NHA | NHA | DZE, NHA | |
| Reason for Predicate/ | ||||
| Reference Device | n/a | Indications for Use; CAD-CAM abutments; | ||
| Referenced sterilization and biocompatibility | Designs and dimensions for Cover Scr | |||
| Abutments, Temporary Abutments, Pr | ||||
| Abutments, Angled Abutments, and T | ||||
| Abutments | ||||
| Abutment Designs | ||||
| Cover Screws | Coronal Ø 3.5 mm | |||
| CH*: 1 mm – 2.8 mm | Diameters 3.5 mm – 10 mm | |||
| Healing Abutments | Coronal Ø 4 mm – 10 mm | |||
| CH: 3 mm – 7 mm | CH: 1 mm – 7 mm | |||
| Temporary Abutments | Prosthetic Platform Ø: 4 mm | |||
| CH: 2 mm | ||||
| Prosthetic Post: 10 mm | Prosthetic Platform Ø: 4 mm – 7 mm | |||
| Prepable Straight Abutments | Prosthetic Platform Ø: 4 mm – 7 mm | |||
| CH: 2 mm – 5 mm | ||||
| Prosthetic Post: 5.5 mm or 7.0 mm | Post Height: 5.5 mm – 10 mm | |||
| Angled Abutments | Prosthetic Platform Ø: | |||
| 4 mm – 7 mm | ||||
| CH: 2 mm – 5 mm | ||||
| Prosthetic Post: 7.0 mm | ||||
| Angle: 15°, 25° | Angulation: 15°, 25° | |||
| Castable Base Abutments-Co-Cr-Mo Alloy | Prosthetic Platform Ø: 3.8 mm | |||
| Angle of final design: 0° | ||||
| Multi-Unit Abutments | Prosthetic Platform Ø: 4.8 mm | |||
| CH: 1.3 mm – 4.5 mm | ||||
| Angle: 0°, 17°, 30° | ||||
| Cylinders (copings) for Multi-unit Abutments | ||||
| Material | ||||
| Prosthetic diameter | ||||
| Overall height | Material: Ti-6Al-4V alloy | |||
| Prosthetic diameter: 4.8 mm | ||||
| Overall height: 12 mm | ||||
| Titanium Base Abutments | Post Height: 4.5 mm or 6 mm | |||
| CH: 0.6 mm and 1.5 mm | ||||
| Angle of final design: 0° | Ti Base | Post Height: | ||
| 4.5 mm, 6 mm, 8 mm | ||||
| CH: 0.6 mm, 1.5 mm, 3.0 mm, 4.0 mm | ||||
| Titanium Blank Abutments | Overall Milling Ø: 10 mm or 12 mm | |||
| Angle of final design: 0° - 30° | Overall Milling Ø: 10 mm or 14 mm | |||
| Abutment-Implant Interface | Internal Connection | Internal Connection | Internal Connection | |
| Abutment Screws | ||||
| Designs | Abutment Multi Post Screw | |||
| Multi-Unit Abutment Screw | ||||
| Multi-Unit Prosthetic Screw | Abutment Screw | Not in 510(k) Summary | ||
| Materials | Ti-6Al-4V | Ti-6Al-4V with DLC coating | Not in 510(k) Summary | |
| Feature | Subject Device | Primary Predicate Device | Predicate Device | Predicate Device |
| K203240 | K191986 | K123988 | K182448 | |
| AccelXTM Abutments | DESS Dental Smart Solutions | AnyOneTM Internal Implant System | AnyRidge Octa 1 Implant System | |
| Integrated Dental Systems LLC | Terrats Medical SL | Mega Gen Implant Co., Ltd | Mega Gen Implant Co., Ltd | |
| Abutment Materials | Titanium alloy (ASTM F136) | Titanium alloy (ASTM F136) | Titanium alloy (ASTM F136) | Ti-6Al-4V-ELI (ASTM F136) |
| Co-Cr-Mo alloy | ||||
| (ASTM F1537) | Co-Cr-Mo alloy | |||
| (ASTM F1537) | Co-Cr-Mo alloy | |||
| (ASTM F1537) | ||||
| Zirconia (ISO 13356) | Zirconia (ISO 13356) | |||
| How Provided - Prosthetic Components | ||||
| Sterility | Non-Sterile | Non-Sterile | Sterile | Sterile |
| Sterilization Method | Moist Heat | Moist Heat | Gamma Sterilization | Gamma Sterilization |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single-use | Single patient, single-use |
| ce | Predicate Device |
|---|---|
| K182448 | |
| ant System | AnyRidge Octa 1 Implant System |
| o., Ltd | MegaGen Implant Co., Ltd |
| DZE, NHA | |
| Screws, Healing | |
| s, Prepable Straight | |
| nd Titanium Base | Designs and dimensions Castable Base Abutment |
| Co-Cr-Mo Alloy and Multi-Unit Abutments | |
| mm | |
| Prosthetic Platform Ø: 3.8 mm | |
| Prosthetic Platform Ø: 4.8 mm | |
| CH: 1.3 mm – 4.3 mm | |
| Angle: 0°, 17°, 30° | |
| Not in 510(k) Summary | |
| Material: Ti-6Al-4V alloy | |
| Prosthetic diameter: 4.8 mm | |
| Overall height: 12 mm | |
| mm | |
| Internal Connection | |
| Abutment Screw | |
| Multi-Unit Abutment Screw | |
| Not in 510(k) Summary |
13
Table of Substantial Equivalence – Technological Characteristics
- CH=Cuff height (gingival height)