(106 days)
The PRE-MILLED 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.
It is compatible with the following systems:
All digitally designed abutments for use with the PRE-MILLED Abutments must be designed and milled through the 3Shape CAD/CAM System and are intended to be sent to a validated milling center for manufacture.
The PRE-MILLED Abutment is compatible with the following devices:
Zimmer 3.1mmD Dental Implant System (K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex
Screw Vent® and Tapered Screw Vent® (K013227)
Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex
Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex
Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex
Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex
The PRE-MILLED Abutment is used in fabricating a patient-specific abutment in titanium alloy. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. It is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136).
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. 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 indications using CAD/CAM system.
Mechanical resistance of the implant-abutment connection is essential to ensure the correct longterm functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of abutments and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
The PRE-MILLED is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.
The proposed abutments are available in internal connection, and are compatible with Zimmer 3.1mmD Dental Implant System (K142082) and Screw Vent® and Tapered Screw Vent® (K013227).
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device (PRE-MILLED Abutment) and focuses on demonstrating substantial equivalence to a predicate device.
The document discusses:
- Device Description: The PRE-MILLED Abutment is used for fabricating patient-specific abutments from titanium alloy, designed via CAD/CAM, and connected to an endosseous dental implant.
- Indications for Use: Support for single or multiple tooth prostheses in partially or fully edentulous patients, compatible with specific Zimmer implant systems.
- Non-clinical Testing:
- Fatigue Test (ISO 14801:2016)
- End User Steam Sterilization Test (ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010)
- Biocompatibility tests (ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010)
- Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
- Conclusion: The non-clinical tests demonstrated substantial equivalence to the primary predicate device, meeting the criteria of the standards. Clinical testing was deemed unnecessary.
However, the document does not explicitly state specific acceptance criteria (e.g., a numerical threshold for fatigue life) and then present detailed results proving those criteria were met. It generally states that "The results of the above tests have met the criteria of the standard and demonstrated the substantial equivalence with the primary predicate."
Therefore, I cannot provide the requested table and detailed study information because it is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
November 25, 2020
MIT Global Co., Ltd. Lim Won Regulatory Affairs Manager 474 Dunchon-daero, Jungwon-gu Seongnam-si, Gyeonggido 13229 SOUTH KOREA
Re: K202269
Trade/Device Name: PRE-MILLED Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 15, 2020 Received: October 26, 2020
Dear Lim Won:
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.
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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.
Andrew Steen Assistant 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
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Indications for Use
510(k) Number (if known) K202269
Device Name PRE-MILLED Abutment
Indications for Use (Describe)
The PRE-MILLED 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.
It is compatible with the following systems:
All digitally designed abutments for use with the PRE-MILLED Abutments must be designed and milled through the 3Shape CAD/CAM System and are intended to be sent to a validated milling center for manufacture.
The PRE-MILLED Abutment is compatible with the following devices:
Zimmer 3.1mmD Dental Implant System (K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex
Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex
Type of Use (Select one or both, as applicable)
| For research and/or ID | For Quality Control or Quality Assurance |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for MIT, which stands for Medical Implant Technology. The letters "MIT" are in red and are slanted to the right. Below the letters, the words "MEDICAL IMPLANT TECHNOLOGY" are written in a smaller, gray font.
510(k) Summary
K202269
Applicant
| Name: | MIT Global Co., Ltd. |
|---|---|
| Address: | 474 Dunchon-daero #501 Jungwong-gu, eongnam-siGyeonggido, 13229 South Korea |
| Phone: | +82 31 745 2838 |
| Contact: | Lim, Rokwon |
| Email: | rokwonlim@mit-global.com |
11/20/2020
Date Prepared:
Subject Device
| Trade Name: | PRE-MILLED Abutment |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name | Abutment, Implant, Dental, Endosseous |
| Product Code: | NHA |
| Panel: | Dental |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
Primary Predicate
| Trade Name: | Medentika CAD/CAM Abutment (K150203) |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name | Abutment, Implant, Dental, Endosseous |
| Product Code: | NHA |
| Panel: | Dental |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
Reference Device
Trade Name:
Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class:
Zimmer 3.1mmD Dental Implant System (K142082) Endosseous dental implant abutment Abutment, Implant, Dental, Endosseous NHA Dental 21 CFR 872.3630 Class II
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Image /page/4/Picture/0 description: The image shows the logo for MIT Medical Implant Technology. The letters "MIT" are in large, red, bold, sans-serif font. Below the letters, the words "MEDICAL IMPLANT TECHNOLOGY" are in a smaller, gray, sans-serif font. The logo is simple and modern.
Reference Device
Trade Name:
Common Name: Classification Name Product Code: Panel: Regulation Number: Device Class:
Screw Vent® and Tapered Screw Vent® (K013227) Endosseous dental implant abutment Abutment, Implant, Dental, Endosseous NHA Dental 21 CFR 872.3630 Class II
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Image /page/5/Picture/0 description: The image shows the logo for MIT Medical Implant Technology. The letters "MIT" are in large, bold, red font and are slanted to the right. Below the letters, the words "MEDICAL IMPLANT TECHNOLOGY" are in a smaller, gray font.
Device Description
The PRE-MILLED Abutment is used in fabricating a patient-specific abutment in titanium alloy. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. It is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136).
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. 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 indications using CAD/CAM system.
Mechanical resistance of the implant-abutment connection is essential to ensure the correct longterm functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of abutments and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
The PRE-MILLED is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.
The proposed abutments are available in internal connection, and are compatible with Zimmer 3.1mmD Dental Implant System (K142082) and Screw Vent® and Tapered Screw Vent® (K013227).
| No. | Implant System | Diameters(Ø) | Implant Platform (mm) | Type of Implant-Abutment Connection |
|---|---|---|---|---|
| 1 | Zimmer 3.1mmD Implant | 3.1 | 2.9 | Internal HexConical Connection |
| 2 | Zimmer SV/TSV | 3.7 | 3.5 | |
| 3 | Zimmer SV/TSV | 4.1 | 3.5 | |
| 4 | Zimmer SV/TSV | 4.7 | 4.5 | |
| 5 | Zimmer SV/TSV | 6.0 | 5.7 |
The PRE-MILLED Abutments are compatible with the following OEM devices:
Indication for Use
The PRE-MILLED 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.
It is compatible with the following systems:
All digitally designed abutments for use with the PRE-MILLED Abutments must be designed and milled through the 3Shape CAD/CAM System and are intended to be sent to a validated milling center for manufacture.
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Image /page/6/Picture/0 description: The image contains the logo for MIT Medical Implant Technology. The logo is red and consists of the letters "MIT" in a bold, stylized font. Below the letters, the words "MEDICAL IMPLANT TECHNOLOGY" are written in a smaller, gray font. The logo is simple and modern, and the use of red and gray gives it a professional look.
The PRE-MILLED Abutment is compatible with the following devices:
Zimmer 3.1mmD Dental Implant System (K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex
Screw Vent® and Tapered Screw Vent® (K013227)
Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex
Summary of Technological Characteristics
The subject device, the primary predicate have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device, the primary predicate 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 primary predicate listed above.
Non-clinical Testing
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- · Fatigue Test according to ISO 14801:2016
- · End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- · Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the primary predicate. The results of the above tests have met the criteria of the standard and demonstrated the substantial equivalence with the primary predicate.
Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worstcase scenario through fatigue testing.
Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant body, the OEM implant abutment, and the OEM abutment screw. The testing aided implant to abutment compatibility and has established substantial equivalency of the proposed device with reference devices.
Clinical testing was not necessary to establish substantial equivalency of the device.
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Image /page/7/Picture/0 description: The image shows the logo for Medical Implant Technology (MIT). The letters "MIT" are in large, red, bold, and italicized font. Below the letters, the words "MEDICAL IMPLANT TECHNOLOGY" are written in a smaller, gray, sans-serif font.
Primary Predicate / Reference devices:
The subject device is substantially equivalent to the following primary predicate and reference devices:
- Primary Predicate
- Medentika CAD/CAM Abutment (K150203) -
- Reference devices
Comparison between Primary predicate
| Feature | Proposed DevicePRE-MILLED Abutment | Primary predicateMedentika CAD/CAMAbutment | SE discussion |
|---|---|---|---|
| Applicant | MIT Global Co., Ltd. | Medentika GmbH | - |
| Trade Name | PRE-MILLED Abutment | Medentika CAD/CAM Abutment | - |
| 510(K) No. | K202269 | K150203 | - |
| ClassificationName | Endosseous Dental Implant Abutments(872.3630) | Endosseous Dental ImplantAbutments (872.3630) | Identical |
| Product Code | NHA | NHA | Identical |
| Screw andAbutmentMaterial | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Identical |
| IndicationsFor Use | The PRE-MILLED Abutments areintended for use with dental implants asa support for single or multiple toothprostheses in the maxilla or mandible ofa partially or fully edentulous patient.It is compatible with the followingsystems:• Zimmer 3.1mmD Dental ImplantSystem (K142082)• Screw Vent® and Tapered ScrewVent® (K013227)All digitally designed abutments for usewith the PRE-MILLED Abutments mustbe designed and milled through the3Shape CAD/CAM System and areintended to be sent to a validated millingcenter for manufacture.The PRE-MILLED Abutment iscompatible with the following devices: | (Medentika TiBase CAD/CAMAbutments not applicable to thissubmission)Medentika Preface CAD/CAMAbutments are intended for use withdental implants as a support for singleor multiple tooth prostheses in themaxilla or mandible of a partially orfully edentulous patient.Image: Table of Implant System CompatibilityMedentika Preface is intended for usewith the Straumann CARES System.All digitally designed abutments foruse with Medentika CAD/CAMAbutments are intended to bemanufactured at a Straumann CARESvalidated milling center. | The subject device is substantiallyequivalent in indications and designprinciples to the primary predicatedevice listed above. Provided tablesare comparing the Indications forUse Statements and thetechnological characteristics of thesubject device, the primarypredicate device. The Indicationsfor Use Statement (IFUS) for thesubject device is substantiallyequivalent in intended use to theprimary predicate device. All areintended for use with endosseousdental implants in the maxilla andmandible to provide functional andesthetic rehabilitation of theedentulous maxilla and mandible.Slight differences in the language ofthe subject device and primarypredicate is Indications for Usestatements do not affect theintended use as an endosseousdental implant abutment for supportof a prosthesis to restore chewingfunction. The minor differencesbetween the subject device and theprimary predicate device are related |
| Feature | Proposed Device | Primary predicateMedentika CAD/CAMAbutment | SE discussion |
| PRE-MILLED Abutment | |||
| Zimmer 3.1mmD Dental Implant System(K142082) Implant Body Diameter 3.1/Implant Platform Diameter 2.9 / InternalHexScrew Vent® and Tapered Screw Vent®(K013227)Implant Body Diameter 3.7/ ImplantPlatform Diameter 3.5 / Internal HexImplant Body Diameter 4.1/ ImplantPlatform Diameter 3.5 / Internal HexImplant Body Diameter 4.7/ ImplantPlatform Diameter 4.5 / Internal HexImplant Body Diameter 6.0/ ImplantPlatform Diameter 5.7 / Internal Hex | to the compatible OEM implantlines and the implant platformdiameter. | ||
| PlatformDiameters | 2.9/3.5/4.5/5.7mm | 3.0 - 7.0 | The difference between thetwo products in the platformdiameter are the same exceptfor the minimum diameter.The minimum diameter ofthe product compatible withthe subject device is smallerthan the primary predicatedevice (K150203). Since theplatform diameter of thesubject device is included inthe range of primarypredicate's diameter,therefore, it doesn't impactthe product's substantialequivalence. |
| CAD DesignLimits | Maximum Angulation : 0 | Maximum Angulation : 0 | The minor difference between thetwo products in the designparameters are the minimummaximum diameter and angulation.The minimum diameter of theproduct compatible with the subjectdevice is larger than the primarypredicate device. The diameter ofthe primary predicate device isØ3.0mm~ Ø7.0mm, while thesubject device can be designed fromØ 4.0mm up to Ø8.0mm. Themaximum angle of the productcompatible with the subject deviceis smaller than the primarypredicate device. The angle of theprimary predicate device is 30°,while the subject device can bedesigned up to 25°. |
| Feature | Proposed DevicePRE-MILLED Abutment | Primary predicateMedentika CAD/CAMAbutment | SE discussion |
| SurfaceTreatment | None | None | - |
| Sterile | Non-sterile | Non-sterile | - |
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Image /page/8/Picture/0 description: The image shows the logo for "MIT MEDICAL IMPLANT TECHNOLOGY". The logo is red and the text below the logo is gray. The logo is a stylized version of the letters "MIT".
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Image /page/9/Picture/0 description: The image shows the logo for MIT Medical Implant Technology. The logo is red and features the letters "MIT" in a bold, slanted font. Below the letters, the words "MEDICAL IMPLANT TECHNOLOGY" are written in a smaller, gray font. The logo is simple and modern, and the use of red and gray gives it a professional look.
Substantial Equivalence Discussion
PRE-MILLED Abutment incorporates the same material, indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the primary predicate.
The Indications for Use of the subject and primary predicate are identical other than the compatible implant bodies. This difference is mitigated by fatigue testing, reverse engineering, dimensional analysis, and identification of reference predicate for compatible implant bodies. Both the predicate and subject devices are intended to be milled into patient-specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.
Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.
PRE-MILLED Abutments are compatible with reference devices (K142082 and K013227). Each PRE-MILLED abutment platform has a precision implant/abutment interface corresponding to the implant system predicate for that platform.
Conclusion
The PRE-MILLED Abutment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its primary predicate. Therefore, PRE-MILLED Abutment and its predicate are substantially equivalent.
§ 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.)