(160 days)
K160784 CAM Titanium Blanks, K171799 Elos Accurate Customized Abutment, K134045 Zimmer Zfx Ti Abutment for NobelActive, NobelReplace CC, K183518, Preat Abutments, K071370, NobelActive Internal Connection Implant, K142260, NobelActive®, K102436, NobelActive 3.0, K062566, NobelReplace Tapered Conical Connection, K173418, NobelParallel™ Concial Connection, K050258, Groovy Implants, K011028, Screw-Vent Dental Implant System, K112160, Tapered Screw-Vent® X Implant
No
The summary describes a CAD/CAM process for fabricating custom abutments, which is a standard digital manufacturing technique and does not inherently involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is described as "Duranext Abutments" which are intended to support dental prostheses, directly interacting with dental implants and patient tissue to restore function.
No
The device is a machinable blank used to create patient-specific dental implant abutments, which serve as a support for prostheses. Its function is restorative, not diagnostic.
No
The device description clearly states that the device is a line of "machinable blanks" and includes physical components like "interface features," "apical end," and a "screw." It is a physical dental implant abutment, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Duranext Abutments are "machinable blanks incorporating interface features compatible with eleven (11) endosseous dental implant system platforms... intended to be milled... to produce patient-specific dental implant abutments." These are physical components used in dental procedures.
- Intended Use: The intended use is "as a support for single or multiple tooth prostheses in the maxilla or mandible." This is a structural and mechanical function within the body, not a diagnostic test performed on a sample.
The device is a dental implant component, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Duranext Abutments are intended for use with dental implants as a support for single or multiple toth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Duranext Abutments from Elegant Direct Corp. are a line of machinable blanks incorporating interface features compatible with eleven (11) endosseous dental implant system platforms (three (3) designs from two (2) manufacturers) and intended to be milled at an Elegant Direct Corp. validated milling center to produce patient-specific dental implant abutments. The subject device platform diameters range from 3.0 mm to 6.0 mm, and the corresponding compatible implant body diameters range from 3.0 mm to 6.0 mm.
Duranext Abutments are designed for fabrication of custom titanium alloy dental implant abutments by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The portion of each abutment available for milling is 9.5 mm in diameter and 20 mm long. The apical end is premanufactured to fit the compatible implant platform, as shown above, and is available in an engaging (anti-rotation) design. A feature at the coronal end of the abutment is provided to interface with the milling equipment. Each abutment is provided with a screw designed to fit the compatible implant. The patient-specific abutment is intended to support a cement-retained single crown or multi-unit restoration.
The design parameters for the CAD/CAM fabrication of custom abutments from Duranext Abutment are:
Minimum wall thickness - 0.5 mm
Minimum post height - 4.0 mm
Maximum abutment height from the prosthetic platform - 20.0 mm
Maximum gingival height - 4.0 mm
Minimum gingival height - 0.5 mm
Angulation - 0° to 30°
Manufacture of CAD/CAM custom abutments from Duranext Abutments is to be performed at an Elegant Direct Corp. validated milling center that is registered with FDA as a medical device manufacturing establishment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 data submitted to demonstrate substantial equivalence included: sterilization according to ISO 17665-1; biocompatibility according to ISO 10993-12; reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; and static compression and compression fatigue testing according to ISO 14801. No clinical data were included in this submission.
Testing to support substantial equivalence included biocompatibility testing according to ISO 10993-5 and ISO 10993-12. In addition, performance testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants was performed to demonstrate that the subject device has sufficient strength for its intended use when tested in dynamic loading.
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.
K150203 Medentika CAD/CAM Abutments
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.
K160784 CAM Titanium Blanks, K171799 Elos Accurate Customized Abutment, K134045 Zimmer Zfx Ti Abutment for NobelActive, NobelReplace CC, K183518, Preat Abutments, K071370, NobelActive Internal Connection Implant, K142260, NobelActive®, K102436, NobelActive 3.0, K062566, NobelReplace Tapered Conical Connection, K173418, NobelParallel™ Concial Connection, K050258, Groovy Implants, K011028, Screw-Vent Dental Implant System, K112160, Tapered Screw-Vent® X Implant
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
July 22, 2020
Elegant Dental Corp. % Floyd Larson President PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K200355
Trade/Device Name: Duranext Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 18, 2020 Received: June 22, 2020
Dear Floyd Larson:
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) K200355
Device Name
Duranext Abutments
Indications for Use (Describe)
Duranext Abutments are intended for use with dental implants as a support for single or multiple toth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Implant System Compatibility | Implant Body
Diameter, mm | Implant Platform |
|--------------------------------------------|------------------------------|------------------|
| NobelActive® (conical connection) | 3.0 | 3.0 (3.0 mm) |
| | 3.5 | NP (3.5 mm) |
| | 4.3, 5.0 | RP (3.9 mm) |
| | 5.5 | WP (5.1 mm) |
| NobelReplace Conical Connection | 3.5 | NP (3.5 mm) |
| | 4.3, 5.0 | RP (3.9 mm) |
| NobelParallel Conical Connection | 3.75 | NP (3.5 mm) |
| | 4.3, 5.0 | RP (3.9 mm) |
| | 5.5 | WP (5.1 mm) |
| NobelReplace® (Internal tri-channel) | 3.5 | NP (3.5 mm) |
| | 4.3 | RP (4.3 mm) |
| | 5.0 | WP (5.0 mm) |
| | 6.0 | 6.0 (6.0 mm) |
| Zimmer Screw Vent®/
Tapered Screw-Vent® | 3.7, 4.1 | 3.5 mm |
| | 4.7 | 4.5 mm |
| | 6.0 | 5.7 mm |
All digitally designed custom abutments for use with Duranext Abutments are to be sent to an Elegant Direct Corp. 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)
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3
510(k) Summary
Duranext Abutments Elegant Direct Corp.
July 21, 2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Elegant Direct Corp.
2308 McDonald Avenue
Brooklyn, NY 11223 | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | Telephone: | +1-718-375-5999 |
| | Fax: | +1-718-375-5983 |
| Official Contact | Gary Fingerman, President | |
| Representative/Consultant | Floyd G. Larson, MS, MBA
Kevin A. Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone:
Fax:
Email: | +1 858-792-1235
+1 858-792-1236
flarson@paxmed.com
kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Duranext Abutments |
|---|---|
| Common Name | Dental implant abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3630, Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Division | DHT1B: Division of Dental Devices |
PREDICATE DEVICE INFORMATION
| Primary predicate device: | K150203 Medentika CAD/CAM Abutments, Medentika GmbH |
|---|---|
| Reference devices: | K160784 CAM Titanium Blanks, Altatec GmbH |
| K171799 Elos Accurate Customized Abutment, Elos Medtech Pinol A/S | |
| K134045 Zimmer Zfx Ti Abutment for NobelActive, NobelReplace CC | |
| Zimmer Dental Inc. |
4
K183518, Preat Abutments, Preat Corporation K071370, NobelActive Internal Connection Implant, Nobel Biocare AB K142260, NobelActive®, Nobel Biocare AB K102436, NobelActive 3.0, Nobel Biocare AB K062566, NobelReplace Tapered Conical Connection, Nobel Biocare USA LLC K173418, NobelParallel™ Concial Connection, Nobel Biocare AB K050258, Groovy Implants, Nobel Biocare AB K011028, Screw-Vent Dental Implant System, Sulzer Dental, Inc. K112160, Tapered Screw-Vent® X Implant, Zimmer Dental, Inc.
INDICATIONS FOR USE STATEMENT
Duranext Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Implant System Compatibility | Implant Body
Diameter, mm | Implant Platform |
|--------------------------------------------|------------------------------|------------------|
| NobelActive® (conical connection) | 3.0 | 3.0 (3.0 mm) |
| NobelActive® (conical connection) | 3.5 | NP (3.5 mm) |
| NobelActive® (conical connection) | 4.3, 5.0 | RP (3.9 mm) |
| NobelActive® (conical connection) | 5.5 | WP (5.1 mm) |
| NobelReplace Conical Connection | 3.5 | NP (3.5 mm) |
| NobelReplace Conical Connection | 4.3, 5.0 | RP (3.9 mm) |
| NobelParallel Conical Connection | 3.75 | NP (3.5 mm) |
| NobelParallel Conical Connection | 4.3, 5.0 | RP (3.9 mm) |
| NobelParallel Conical Connection | 5.5 | WP (5.1 mm) |
| NobelReplace® (Internal tri-channel) | 3.5 | NP (3.5 mm) |
| NobelReplace® (Internal tri-channel) | 4.3 | RP (4.3 mm) |
| NobelReplace® (Internal tri-channel) | 5.0 | WP (5.0 mm) |
| NobelReplace® (Internal tri-channel) | 6.0 | 6.0 (6.0 mm) |
| Zimmer Screw Vent®/
Tapered Screw-Vent® | 3.7, 4.1 | 3.5 mm |
| Zimmer Screw Vent®/
Tapered Screw-Vent® | 4.7 | 4.5 mm |
| Zimmer Screw Vent®/
Tapered Screw-Vent® | 6.0 | 5.7 mm |
All digitally designed custom abutments for use with Duranext Abutments are to be sent to an Elegant Direct Corp. validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
Duranext Abutments from Elegant Direct Corp. are a line of machinable blanks incorporating interface features compatible with eleven (11) endosseous dental implant system platforms (three (3) designs from two (2) manufacturers) and intended to be milled at an Elegant Direct Corp. validated milling center to produce patientspecific dental implant abutments. The subject device platform diameters range from 3.0 mm to 6.0 mm, and the corresponding compatible implant body diameters range from 3.0 mm to 6.0 mm.
5
Duranext Abutments are designed for fabrication of custom titanium alloy dental implant abutments by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The portion of each abutment available for milling is 9.5 mm in diameter and 20 mm long. The apical end is premanufactured to fit the compatible implant platform, as shown above, and is available in an engaging (anti-rotation) design. A feature at the coronal end of the abutment is provided to interface with the milling equipment. Each abutment is provided with a screw designed to fit the compatible implant. The patient-specific abutment is intended to support a cement-retained single crown or multi-unit restoration.
The design parameters for the CAD/CAM fabrication of custom abutments from Duranext Abutment are:
Minimum wall thickness - 0.5 mm Minimum post height - 4.0 mm Maximum abutment height from the prosthetic platform - 20.0 mm Maximum gingival height - 4.0 mm Minimum gingival height - 0.5 mm Angulation - 0° to 30°
Manufacture of CAD/CAM custom abutments from Duranext Abutments is to be performed at an Elegant Direct Corp. validated milling center that is registered with FDA as a medical device manufacturing establishment.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included: sterilization according to ISO 17665-1; biocompatibility according to ISO 10993-12; reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; and static compression and compression fatigue testing according to ISO 14801. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
With regard to intended use, the subject Duranext Abutment is substantially equivalent to the primary predicate device, K 150203 Medentika CAD/CAM Abutments and to the abutment reference devices K160784 CAM Titanium Blanks, K171799 Elos Accurate Customized Abutment and K134045 Zimmer Zfx Ti Abutment for NobelReplace CC. All are intended for use with dental implants as a support for single tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. While the primary predicate device is intended for use with the Straumann CARES System, digitally designed abutments for use with the abutment reference devices are intended to be sent to a validated milling center for manufacture, as is the case for the subject device. With regard to OEM implant system compatibility, all subject device compatibilities are included in those for the primary predicate device, with the exception of the WP (5.5) platform of the NobelParallel Conical Connection implants. Slight differences in the wording of the Indications for Use do not affect the intended use of the device to support a single-tooth or multiple-unit prosthesis for restoration of chewing function.
With regard to design, the subject device, the primary predicate device and abutment reference devices all are titanium alloy blanks intended to be used for the manufacture of patient-specific abutments using CAD/CAM techniques, with manufacture of the final finished device performed at a validated milling center - an Establishment that is registered with FDA as a manufacturer. The design parameters intended for the subject device are substantially equivalent to those of the primary predicate device; maximum angulation for each is 30°, maximum abutment height is 20 mm and minimum post height is 4 mm, maximum gingival height for the subject
6
510(k) Summary Page 4 of 7
device is 4 mm, which is not a worse case than the 6 mm maximum gingival height of the primary predicate device.
Testing to support substantial equivalence included biocompatibility testing according to ISO 10993-5 and ISO 10993-12. In addition, performance testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants was performed to demonstrate that the subject device has sufficient strength for its intended use when tested in dynamic loading.
CONCLUSION
The subject device, the primary predicate device, and the abutment reference devices have intended use, have similar technological characteristics, and are materials. The subject device, the primary predicate, and reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
7
| Subject Device | ||||
|---|---|---|---|---|
| Duranext Abutments | ||||
| Elegant Direct Corp. | Duranext Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or | |||
| mandible of a partially or fully edentulous patient | ||||
| Implant System Compatibility | Implant Body Diameter, mm | Implant Platform | ||
| NobelActive® (conical connection) | 3.0 | 3.0 (3.0 mm) | ||
| 3.5 | NP (3.5 mm) | |||
| 4.3, 5.0 | RP (3.9 mm) | |||
| 5.5 | WP (5.1 mm) | |||
| NobelReplace Conical Connection | 3.5 | NP (3.5 mm) | ||
| 4.3, 5.0 | RP (3.9 mm) | |||
| NobelParallel Conical Connection | 3.75 | NP (3.5 mm) | ||
| 4.3, 5.0 | RP (3.9 mm) | |||
| NobelReplace® (Internal tri-channel) | 3.5 | NP (3.5 mm) | ||
| 4.3 | RP (4.3 mm) | |||
| 5.0 | WP (5.0 mm) | |||
| 6.0 | 6.0 (6.0 mm) | |||
| Zimmer Screw Vent®/ | ||||
| Tapered Screw-Vent® | 3.7, 4.1 | 3.5 mm | ||
| 4.7 | 4.5 mm | |||
| 6.0 | 5.7 mm | |||
| Primary Predicate Device | All digitally designed custom abutments for use with Duranext Abutments are to be sent to an Elegant Direct validated milling | |||
| center for manufacture. | ||||
| K150203 | ||||
| Medentika CAD/CAM Abutments | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple | |||
| tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | ||||
| (Preface) | Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) |
| Medentika GmbH | Nobel Biocare Replace™ Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive™ | F | 3.0, 3.5, 4.3, 5.0 | 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) | |
| Biomet 3i Osseotite® Certain® | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| Biomet 3i Osseotite® | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| Nobel Biocare Brånemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 | |
| Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | |
| Straumann Standard | N | 3.3, 4.1, 4.8 | 3.5(NNC), 4.8, 6.5 | |
| Zimmer Tapered Screw-vent® | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | |
| Astra Tech OsseoSpeed™ | S | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5, 4.0, 4.5, 5.0 | |
| Dentsply Friadent® Frialit/XiVE® | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | |
| Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with | ||||
| Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center |
Device Comparison Table of Substantial Equivalence – Indications for Use Statements
8
| Reference Devices | |||
|---|---|---|---|
| K160784 | |||
| CAM Titanium Blanks | |||
| Altatec GmbH | CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREWLINE | ||
| and CAMLOG® ROOT-LINE [, on CONELOG SCREWLINE or on iSy] implants in the maxilla and mandible for the purpose of | |||
| supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with | |||
| CAD/CAM techniques for use with CAMLOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling | |||
| center for manufacture. | |||
| K171799 | |||
| Elos Accurate® Customized Abutment | |||
| Elos Medtech Pinol A/S | The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or | ||
| multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the | |||
| included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the following implant systems: | |||
| Ref. No. | Platform compatibility | Implant diameter | |
| AB-BRA411213-US | Nobel Biocare® / Brånemark® RP | 3.75 mm & 4 mm | |
| AB-BRA351213-US | Nobel Biocare® / Brånemark® NP | 3.3 mm | |
| AB-BRA511213-US | Nobel Biocare® / Brånemark® WP | 5 mm | |
| All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an Elos Medtech approved milling | |||
| facility. | |||
| K134045 | |||
| Zimmer Zfx Titanium Abutment for | |||
| NobelActive Implant System | |||
| Zimmer Dental Inc. | The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for | ||
| cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a | |||
| Narrow Platform (NP) Ø 3.5mm or a Regular Platform (RP) Ø 3.9mm. |
9
| Comparison | Subject Device | Primary Predicate
Device | Reference Devices | | |
|----------------------------------------------|----------------------------|------------------------------------------|----------------------------|---------------------------------------|--------------------------------------------|
| | | K150203 | K160784 | K171799 | K134045
Zimmer Zfx Titanium |
| | Duranext Abutments | Medentika CAD/CAM
Abutments (Preface) | CAM Titanium Blanks | Elos Accurate® Customized
Abutment | Abutment for NobelActive
Implant System |
| | Elegant Direct Corp. | Medentika GmbH | Altatec GmbH | Elos Medtech Pinol A/S | Zimmer Dental Inc. |
| Design | | | | | |
| Abutment Blank | CAD/CAM Blank | CAD/CAM Blank | CAD/CAM Blank | CAD/CAM Blank | CAD/CAM Blank |
| CAD/CAM Abutment Design Parameters | | | | | |
| Minimum post height, mm | 4 | 4 | Not stated | Not stated | 3 |
| Maximum gingival height, mm | 4 | 6 | Not stated | Not stated | Not stated |
| Maximum abutment height, mm | 20 | 20 | Not stated | Not stated | 12 |
| Maximum abutment angulation | 30° | 30° | 30° | 20° | 25° |
| Abutment attachment to implant | Screw | Screw | Screw | Screw | Screw |
| Prosthesis attachment to abutment | Cement | Cement | Cement | Cement | Cement |
| Restoration | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-unit,
Multi-unit | Single-unit,
Multi-unit |
| Abutment/implant
platform
diameter, mm | 3.0 - 5.7 | 3.0 - 6.0 | 3.3 - 6.0 | 3.5 - 5.1 | 3.5, 3.9 |
| Abutment/ Implant Interface | Internal | Internal | Internal | External | Internal |
| Material | | | | | |
| Abutment | Ti-6Al-4V ELI | Ti alloy | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V |
| Screw | Ti-6Al-4V ELI | Ti alloy | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti alloy |