(198 days)
Medentika 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.
Medentika Abutment System is an abutment system including ten abutment designs compatible with eleven currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21 °
The provided text is a 510(k) summary for the Medentika Abutment System, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The context of this type of document is a regulatory submission, not a study evaluating AI performance or a diagnostic device. Therefore, the questions related to AI, ground truth establishment, expert consensus, sample sizes for AI training/testing, adjudication methods, and MRMC studies are not applicable to the information contained in this document. The document describes a "substantial equivalence" claim for a physical medical device (dental abutments), meaning it demonstrates the device is as safe and effective as a legally marketed device.
Here's the information that can be extracted or inferred based on the provided text, with responses to your questions where applicable and an explanation when not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it refers to regulatory compliance and equivalence to predicate devices. The "reported device performance" is demonstrated through various non-clinical tests designed to show the physical and mechanical properties are comparable to existing, legally marketed devices.
| Acceptance Criteria (Implied by Regulatory Standards & Equivalence) | Reported Device Performance (Demonstrated by Testing) |
|---|---|
| Sterilization Validation (ISO 17665-1, ISO 17665-2) | Sterilization validated according to ISO 17665-1 (Requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO 17665-2 (Guidance on the application of ISO 17665-1). (Specific performance outcomes not detailed, but compliance is implied by meeting the standard). |
| Biocompatibility Testing (ISO 10993-5) | Biocompatibility testing performed according to ISO 10993-5 (Tests for in vitro cytotoxicity). (Specific performance outcomes not detailed, but compliance is implied by meeting the standard). |
| Mechanical Strength/Durability (ISO 14801) | Static and dynamic compression-bending testing performed according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). (Specific performance outcomes not detailed, but the data is stated to demonstrate substantial equivalence to predicate devices, implying comparable mechanical performance). |
| Engineering and Dimensional Characteristics | Engineering analysis and dimensional analysis were performed. (Specific details not provided, but these analyses would confirm the device's design and measurements meet specifications and are comparable to predicate devices). |
| Overall Substantial Equivalence to Predicate Devices | The data demonstrates substantial equivalence to "K020646 Replace™ HA Coated Implant", "K071370 NobelActive Internal Connection Implant", "K063341 3i OSSEOTITE Certain® Dental Implants", "K063286 OSSEOTITE Dental Implants", "K022562 Various Brånemark System Implants – Immediate Function Indication", "K062129 P.004 Implants", "K130222 Straumann Dental Implant System SLActive and Roxoid Product Families", "K061410 Zimmer Dental Implant System", "K101732 Astra Tech Implant System", "K073075 FRIADENT Implant Systems", "K041509 ANKYLOS® Dental Implant System", "K072570 NobelActive Multi-Unit Abutment", "K093643 Multi-Unit Abutments for Straumann and Astra Tech Implant Systems", "K072878 Locator Implant Anchor", "K092434 2.2 mm Angled Micro ERA Dental Implant System", "K120414 OsseoSpeed™ Plus", "K083496 CAMLOG Implant System Modified Implants and Abutments", and "K080239 P.004 RC/NC Bar and Bridge Abutments Line". This implies that the safety and efficacy profiles are comparable. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical testing data" for sterilization, biocompatibility, engineering, dimensional, and static/dynamic compression-bending tests. These types of tests typically involve a sample of units for each test, but the specific number of units is not detailed in this summary. The data provenance is also not specified, though the manufacturer (Medentika GmbH) is based in Germany. The tests are prospective in nature, as they involve testing the actual device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. This document describes a medical device approval based on physical properties and comparison to predicate devices, not an AI or diagnostic study requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There is no "test set" in the context of expert review or diagnostic assessment for this type of device approval.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This is a physical medical device (dental abutment), not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This question is not applicable in the context of expert-determined ground truth for a diagnostic task. For this device, the "ground truth" equivalent would be established by:
- Established ISO standards: For sterilization (ISO 17665-1, ISO 17665-2), biocompatibility (ISO 10993-5), and mechanical fatigue (ISO 14801). Compliance with these standards is considered the "truth" for safety and performance in their respective domains.
- Performance of predicate devices: The "truth" is that the predicate devices are legally marketed and considered safe and effective. The subject device demonstrates comparable performance to these established devices.
8. The sample size for the training set
This question is not applicable. This document describes the approval of a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" in the context of AI for this device approval.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
Medentika GmbH c/o Ms. Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K142167
Trade/Device Name: Medentika Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: January 21, 2015 Received: January 22, 2015
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 yours,
Tina Kiang
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Indications for Use
K142167 510(k) Number:
Device Name: Medentika Abutment System
Medentika 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.
Abutments are compatible with the following implant systems:
| Implant System | Series | Implant Diameters (mm) |
|---|---|---|
| Nobel Biocare Replace Select | E -Series | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive | F -Series | 3.5, 4.3, 5.0 |
| Biomet 3i Osseotite® Certain | H -Series | 3.25, 4.0, 5.0 |
| Biomet 3i Osseotite | I -Series | 3.25, 3.75, 4.0, 5.0 |
| Nobel Biocare Branemark | K -Series | 3.3, 3.75, 4.0, 5.0 |
| Straumann Bone Level | L -Series | 3.3, 4.1, 4.8 |
| Straumann Standard | N -Series | 3.3, 4.1, 4.8 |
| Zimmer Tapered Screw-vent | R -Series | 3.3, 3.7, 4.1, 4.7, 6.0 |
| Astra Tech OsseoSpeed | S -Series | 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent Frialit/Xive | T -Series | 3.4, 3.8, 4.5, 5.5 |
| Dentsply Friadent Ankylos | Y -Series | 3.5, 4.5, 5.5, 7.0 |
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary Medentika GmbH Medentika Abutment System
February 19, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medentika GmbHHammweg 8-1076549 Hügelsheim, GermanyTelephone +49 (0)7229-69912-0Fax +49 (0)7229-69912-20 |
|---|---|
| Official Contact | Gerhard PolzerHead of Quality Management / Regulatory Affair |
| Representative/Consultant | Linda K. SchulzFloyd G. LarsonPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236Email: LSchulz@paxmed.comFLarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Medentika Abutment System |
|---|---|
| Common Name | Endosseous 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 Branch | Dental Devices Branch |
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INTENDED USE
Medentika 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 | Series | Implant Diameters (mm) |
|---|---|---|
| Nobel Biocare Replace Select | E -Series | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive | F -Series | 3.5, 4.3, 5.0 |
| Biomet 3i Osseotite® Certain | H -Series | 3.25, 4.0, 5.0 |
| Biomet 3i Osseotite | I -Series | 3.25, 3.75, 4.0, 5.0 |
| Nobel Biocare Branemark | K -Series | 3.3, 3.75, 4.0, 5.0 |
| Straumann Bone Level | L -Series | 3.3, 4.1, 4.8 |
| Straumann Standard | N -Series | 3.3, 4.1, 4.8 |
| Zimmer Tapered Screw-vent | R -Series | 3.3, 3.7, 4.1, 4.7, 6.0 |
| Astra Tech OsseoSpeed | S -Series | 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent Frialit/Xive | T -Series | 3.4, 3.8, 4.5, 5.5 |
| Dentsply Friadent Ankylos | Y -Series | 3.5, 4.5, 5.5, 7.0 |
Abutments are compatible with the following implant systems:
DEVICE DESCRIPTION
Medentika Abutment System is an abutment system including ten abutment designs compatible with eleven currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21 °
EQUIVALENCE TO MARKETED DEVICE
| K020646 | Replace™ HA Coated Implant |
|---|---|
| K071370 | NobelActive Internal Connection Implant |
| K063341 | 3i OSSEOTITE Certain® Dental Implants |
| K063286 | OSSEOTITE Dental Implants |
| K022562 | Various Brånemark System Implants – Immediate Function Indication |
| K062129 | P.004 Implants |
| K130222 | Straumann Dental Implant System SLActive and Roxoid Product Families |
| K061410 | Zimmer Dental Implant System |
| K101732 | Astra Tech Implant System |
| K073075 | FRIADENT Implant Systems |
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| K041509 | ANKYLOS® Dental Implant System |
|---|---|
| K072570 | NobelActive Multi-Unit Abutment |
| K093643 | Multi-Unit Abutments for Straumann and Astra Tech Implant Systems |
| K072878 | Locator Implant Anchor |
| K092434 | 2.2 mm Angled Micro ERA Dental Implant System |
| K120414 | OsseoSpeed™ Plus |
| K083496 | CAMLOG Implant System Modified Implants and Abutments |
| K080239 | P.004 RC/NC Bar and Bridge Abutments Line |
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: Sterilization validation according to ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1, biocompatibility testing according to ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity, engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.
Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use, ●
- uses the same operating principle,
- . incorporates the same basic design,
- . incorporates the same or very similar materials, and
- has similar packaging and is sterilized using the same materials and processes. ●
§ 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.)