K Number
K142167
Device Name
MEDENTIKA ABUTMENT SYSTEM
Manufacturer
Date Cleared
2015-02-20

(198 days)

Product Code
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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 °
More Information

No
The description focuses on the mechanical design and compatibility of dental abutments, with no mention of AI or ML capabilities. The performance studies are based on standard mechanical and biological testing.

No
Therapeutic devices are generally defined as devices that treat or prevent a disease or condition. This device, an abutment, supports dental prostheses and does not directly treat or prevent a disease.

No

The device is an abutment system for dental implants used to support prostheses, not to diagnose a condition.

No

The device description and performance studies clearly indicate this is a system of physical abutments made of materials requiring sterilization and biocompatibility testing, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for supporting dental prostheses in the maxilla or mandible. This is a direct therapeutic or restorative application within the body.
  • Device Description: The description details the physical components and their function in supporting dental prostheses.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The performance studies focus on mechanical and biological compatibility, not diagnostic accuracy.

IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health, or determine compatibility. This device is a physical component used in dental restoration.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

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 °

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

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 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.

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.

K020646, K071370, K063341, K063286, K022562, K062129, K130222, K061410, K101732, K073075, K041509

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.

K072570, K093643, K072878, K092434, K120414, K083496, K080239

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/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.

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 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

2

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 SystemSeriesImplant Diameters (mm)
Nobel Biocare Replace SelectE -Series3.5, 4.3, 5.0, 6.0
Nobel Biocare NobelActiveF -Series3.5, 4.3, 5.0
Biomet 3i Osseotite® CertainH -Series3.25, 4.0, 5.0
Biomet 3i OsseotiteI -Series3.25, 3.75, 4.0, 5.0
Nobel Biocare BranemarkK -Series3.3, 3.75, 4.0, 5.0
Straumann Bone LevelL -Series3.3, 4.1, 4.8
Straumann StandardN -Series3.3, 4.1, 4.8
Zimmer Tapered Screw-ventR -Series3.3, 3.7, 4.1, 4.7, 6.0
Astra Tech OsseoSpeedS -Series3.5, 4.0, 4.5, 5.0
Dentsply Friadent Frialit/XiveT -Series3.4, 3.8, 4.5, 5.5
Dentsply Friadent AnkylosY -Series3.5, 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)

Page 1 of 1

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510(k) Summary Medentika GmbH Medentika Abutment System

February 19, 2015

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Medentika GmbH
Hammweg 8-10
76549 Hügelsheim, Germany
Telephone +49 (0)7229-69912-0
Fax +49 (0)7229-69912-20 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Gerhard Polzer
Head of Quality Management / Regulatory Affair |
| Representative/Consultant | Linda K. Schulz
Floyd G. Larson
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
FLarson@paxmed.com |

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary NameMedentika Abutment System
Common NameEndosseous dental implant abutment
Classification NameEndosseous dental implant abutment
Classification Regulations21 CFR 872.3630, Class II
Product CodeNHA
Classification PanelDental Products Panel
Reviewing BranchDental 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 SystemSeriesImplant Diameters (mm)
Nobel Biocare Replace SelectE -Series3.5, 4.3, 5.0, 6.0
Nobel Biocare NobelActiveF -Series3.5, 4.3, 5.0
Biomet 3i Osseotite® CertainH -Series3.25, 4.0, 5.0
Biomet 3i OsseotiteI -Series3.25, 3.75, 4.0, 5.0
Nobel Biocare BranemarkK -Series3.3, 3.75, 4.0, 5.0
Straumann Bone LevelL -Series3.3, 4.1, 4.8
Straumann StandardN -Series3.3, 4.1, 4.8
Zimmer Tapered Screw-ventR -Series3.3, 3.7, 4.1, 4.7, 6.0
Astra Tech OsseoSpeedS -Series3.5, 4.0, 4.5, 5.0
Dentsply Friadent Frialit/XiveT -Series3.4, 3.8, 4.5, 5.5
Dentsply Friadent AnkylosY -Series3.5, 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

K020646Replace™ HA Coated Implant
K071370NobelActive Internal Connection Implant
K0633413i OSSEOTITE Certain® Dental Implants
K063286OSSEOTITE Dental Implants
K022562Various Brånemark System Implants – Immediate Function Indication
K062129P.004 Implants
K130222Straumann Dental Implant System SLActive and Roxoid Product Families
K061410Zimmer Dental Implant System
K101732Astra Tech Implant System
K073075FRIADENT Implant Systems

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K041509ANKYLOS® Dental Implant System
K072570NobelActive Multi-Unit Abutment
K093643Multi-Unit Abutments for Straumann and Astra Tech Implant Systems
K072878Locator Implant Anchor
K0924342.2 mm Angled Micro ERA Dental Implant System
K120414OsseoSpeed™ Plus
K083496CAMLOG Implant System Modified Implants and Abutments
K080239P.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. ●