(178 days)
Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.
Dentium CAD/CAM Abutments are titanium abutments to be used in fabricating patient-specific abutments. Each patient-specific abutment is individually prescribed by the clinician. Dentium CAD/CAM Ti-Blank Abutments are abutments with a pre-manufactured precision interface and are used by a validated milling center to fabricate patient-specific abutments. Ti-Blanks are available in three cylinder diameters (10 mm, 14 mm, and 15.8 mm) and three connection designs (Hex, Long Hex). Dentium CAD/CAM Custom Abutments are patient-specific abutments fabricated by Dentium. Custom Abutments are available for fabrication in three connection designs (Hex, Long Hex, and Non-hex). Dentium CAD/CAM Abutments are available for four corresponding implant platform diameters (3.6 mm. 4.0 mm, 4.5 mm, 5.0 mm). Each abutment is supplied with a corresponding abutment screw, cleared previously in K141457. All subject device abutments are compatible with Implantium dental implants.
I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for Dentium CAD/CAM Abutments does not contain any information about acceptance criteria or a study proving that an AI/device meets acceptance criteria related to diagnostic performance.
The document is a clearance letter for a dental device (CAD/CAM abutments), not an AI or diagnostic imaging device. It focuses on demonstrating substantial equivalence to predicate devices based on:
- Non-clinical performance data: steam sterilization validation, biocompatibility, and dynamic compression-bending testing.
- Design similarities: material, size, and interface.
- Intended use.
Therefore, I cannot extract the information required by your request, such as a table of acceptance criteria for diagnostic performance, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, or training set details, because this document is for a medical device that does not involve such diagnostic performance evaluations.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
Dentium Co., Ltd c/o Ms. Linda Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K161713
Trade/Device Name: Dentium CAD/CAM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 16, 2016 Received: November 17, 2016
Dear Ms. Schulz:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang" in a clear, legible font. Below the name, there is a small "-s" which likely indicates a signed document. The signature is complex and stylized, featuring looping lines and curves that create an artistic design to the left of the name. The overall impression is that this is a formal document or certification that has been officially signed.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Dentium CAD/CAM Abutments
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| --------------- | -------------------------------------------------------------------------- | ----------------------------------------------------------- |
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510(k) Summary
Dentium Co., Ltd.
Dentium CAD/CAM Abutments
December 14, 2016
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Dentium Co., Ltd. | |||
|---|---|---|---|---|
| 150, Eondong-ro, Giheung-gu | ||||
| Yongin-si, Gyeonggi-do, 443-270 | ||||
| Republic of Korea | ||||
| Telephone: | +82-31-207-2200 | |||
| Fax: | +82-31-207-3883 | |||
| Official Contact | Sangpil Yoon, Team Manager of Regulatory Affairs | |||
| Representative/Consultant | Linda K. Schulz, BSDH, RDH | |||
| Kevin A. Thomas, PhD | ||||
| PaxMed International, LLC | ||||
| 12264 El Camino Real, Suite 400 | ||||
| San Diego, CA 92130 | ||||
| Telephone: | +1 (858) 792-1235 | |||
| Fax: | +1 (858) 792-1236 | |||
| Email: | LSchulz@paxmed.com | |||
| KThomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Dentium CAD/CAM Abutments |
|---|---|
| Common Name | Abutment, implant, dental, endosseous |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations | 21 CFR 872.3630 |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
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PREDICATE DEVICE INFORMATION
| Primary Predicate for Ti-Blank | ||
|---|---|---|
| K150203 | Medentika CAD/CAM Abutments | Medentika GmbH |
| Primary Predicate for Custom Abutment | ||
| K103020 | Atlantis™ Abutment for Keystone Implant | Astra Tech, Inc. |
| Reference Predicate | ||
| K141457 | Dentium Implantium® and SuperLine® Abutments | Dentium Co., Ltd. |
| K070228 | Implantium® Prosthetics | Dentium Co., Ltd. |
| K041368 | Dentium Company Limited Implantium | Dentium Co., Ltd. |
| K092341 | Low Profile Abutment | Biomet 3i, Inc. |
INDICATIONS FOR USE
Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.
DEVICE DESCRIPTION
Dentium CAD/CAM Abutments are titanium abutments to be used in fabricating patient-specific abutments. Each patient-specific abutment is individually prescribed by the clinician. Dentium CAD/CAM Ti-Blank Abutments are abutments with a pre-manufactured precision interface and are used by a validated milling center to fabricate patient-specific abutments. Ti-Blanks are available in three cylinder diameters (10 mm, 14 mm, and 15.8 mm) and three connection designs (Hex, Long Hex). Dentium CAD/CAM Custom Abutments are patient-specific abutments fabricated by Dentium. Custom Abutments are available for fabrication in three connection designs (Hex, Long Hex, and Non-hex). Dentium CAD/CAM Abutments are available for four corresponding implant platform diameters (3.6 mm. 4.0 mm, 4.5 mm, 5.0 mm). Each abutment is supplied with a corresponding abutment screw, cleared previously in K141457. All subject device abutments are compatible with Implantium dental implants.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: steam sterilization validation according to ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10 th; biocompatibility demonstrated by the referenced Dentium submission, K070228, using the same materials and manufacturing processes as the subject device; and dynamic compression-bending testing according to ISO 14801, showing mechanical performance equivalent to predicate devices.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the technological characteristics and the Indications for Use of the subject device abutments and the predicate device abutments.
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| Summary: Table of Substantial Equivalence – Indications for Use | ||||
|---|---|---|---|---|
| Subject Device | Indications for Use | |||
| Dentium Co., Ltd.DentiumCAD/CAMAbutmentsK161713 | Dentium abutments are intended for use on endosseous dental implants in the edentulous or partiallyedentulous maxilla or mandible, as an aid in prosthetic rehabilitation.All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent toa Dentium-validated milling center for manufacture. | |||
| Primary PredicateDevices | ||||
| Medentika GmbHMedentikaCAD/CAMAbutmentsK150203(Indications forUse shown arefor MedentikaPreface only) | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support forsingle or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | |||
| Implant System Compatibility | Series | Implant Diameter(mm) | Platform Diameter(mm) | |
| 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 designedabutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at aStraumann® CARES® validated milling center. | ||||
| Astra Tech, Inc.Atlantis™Abutment forKeystone ImplantK103020 | The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device ina partially or completely edentulous patient. It is intended for use to support single and multiple toothprosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to theabutment. The abutment screw is intended to secure the abutment to the endosseous implant.This device is compatible with the following manufacturers' implant systems:The titanium abutments are compatible with the Keystone 3.5mm, 4.0mm, 4.1mm and 5.0mm KeystoneImplants.The zirconia abutments are compatible with the Keystone 3.5mm, 4.0mm, 4.1mm and 5.0mmKeystone Implants.Please note: This device may be used in an early load situation, but is dependent on the specificimplant system and protocol used by the dental professional.Highly angled abutments on small diameter implants are intended for the anterior region only. | |||
| ReferencePredicate Device | ||||
| Dentium Co. Ltd.DentiumImplantium® andSuperLine®AbutmentsK141457 | Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation | |||
| Dentium Co. Ltd.ImplantiumProstheticsK070228 | Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation. | |||
| Biomet 3i, Inc.Low ProfileAbutmentK092341 | BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implantsto support a prosthetic device in a partially or completely edentulous patient. A dental abutment isintended for use to support single and multiple tooth prostheses, in the mandible or maxilla. Theprosthesis is screw retained to the abutment. |
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| Summary: Table of Substantial Equivalence – Abutment Technological Characteristics | ||||||
|---|---|---|---|---|---|---|
| Subject Device | Primary Predicate Devices | Reference Predicate Devices | ||||
| Comparison | Dentium Co., Ltd.DentiumCAD/CAMAbutment | Medentika GmbHMedentikaCAD/CAMAbutments | Astra Tech, Inc.Atlantis™Abutment forKeystoneImplant | Dentium Co.Ltd.ImplantiumProsthetics | Dentium Co.Ltd.DentiumImplantium® andSuperLine®Abutments | Biomet 3i, Inc.Low ProfileAbutment |
| K161713 | K150203 | K103020 | K070228 | K141457 | K092341 | |
| Design | ||||||
| Abutment Design | CAD/CAM Blank,Custom Abutment | CAD/CAM Blank,TiBase | CAD/CAMCustomAbutment | Multiple Designs | Multiple Designs | Screw-retainedAbutment |
| ProsthesisAttachment | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained | Screw-retained |
| Restoration | Single-unit,Multi-unit | Single-unit.Multi-unit | Single-unit,Multi-unit | Single-unit.Multi-unit | Single-unit,Multi-unit | Single-unit,Multi-unit |
| CorrespondingImplantPlatformDiameter (mm) | 3.6 - 5.0 | 3.0 - 6.0 | 3.5 - 5.0 | Unknown | 3.6 - 5.0 | 3.4 - 5.0 |
| Abutment Angle | Up to 30° | Up to 30° | Up to 30° | Straight | Up to 30° | Up to 30° |
| Abutment/ ImplantInterface | Internal | Internal, External | Internal | Internal | Internal | Internal |
| Material | ||||||
| Abutment | CPTi | Titanium Alloy | Titanium Alloy,Y-TZP | CPTi,Titanium Alloy,Gold Alloy | CPTi, TitaniumAlloy, CoCr,Gold Alloy | TitaniumAlloy |
The subject device Ti-Blank is substantially equivalent to the predicate K150203 in design, function, manufacture and intended use. Both are cylindrical titanium abutments with a precision implant/abutment interface for use in fabricating a patient-specific abutment at a manufacturer-validated milling center. The subject device is different from the predicate device in implant/abutment interface, specific cylinder size, and specific abutment diameters. However, the subject device sizes are within the size range of the primary predicate.
The subject device Custom Abutment is substantially equivalent to K103020 in design, function, manufacture and intended use. Both are patient-specific abutments fabricated by the manufacturer. The subject device is different from the predicate device in implant/abutment interface, specific abutment sizes and manufacturer. However, the subject device sizes are within the size range of the primary predicate. The final finished Custom Abutment differs from the Ti-Blank and primary predicate in manufacturing flow only.
All subject device abutments and predicate abutments are by prescription order from a clinician, and have the same implant/abutment interface as the reference predicate K141457. All are compatible with Dentium Implantium implants (K041368). Subject device design parameters are substantially equivalent to K150203, K103020, and K092341.
Minor differences in the language or in device-specific details of the indications for use statement for the subject device as compared to the predicate devices do not change the intended use of abutments to be used with endosseous dental implants for prosthetic rehabilitation in the maxilla and mandible. The subject device Indications for Use statement does not include a compatibility table because it is not claiming compatibility with other manufacturers' devices. Therefore, these minor differences in language do not affect the determination of substantial equivalence.
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Mechanical testing performed for the subject device shows that it is strong enough for its intended use and is equivalent to the predicate devices listed above.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject devices encompass the same range of physical dimensions, including diameter, gingival height, and angle of the abutments. The subject and predicate devices 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.
§ 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.)