MEDENTIKA ABUTMENT SYSTEM

K142167 · Medentika GmbH · NHA · Feb 20, 2015 · Dental

Device Facts

• Record ID: K142167
• Device Name: MEDENTIKA ABUTMENT SYSTEM
• Applicant: Medentika GmbH
• Product Code: NHA · Dental
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

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 Story

Medentika Abutment System consists of ten abutment designs compatible with eleven specific dental implant systems. Abutments support cement-retained, screw-retained, or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm; angled designs feature up to 21° angulation. Used by dental professionals in clinical settings to connect prosthetic teeth to endosseous implants. Device provides structural support for dental restorations, facilitating patient oral function and aesthetics.

Clinical Evidence

Bench testing only. Evidence includes sterilization validation (ISO 17665-1/2), biocompatibility testing (ISO 10993-5), engineering analysis, dimensional analysis, and static/dynamic compression-bending testing per ISO 14801.

Technological Characteristics

Endosseous dental implant abutments; platform diameters 3.3-7.0 mm; angled designs up to 21°. Materials and manufacturing processes are similar to predicate devices. Sterilization via moist heat per ISO 17665-1/2. Mechanical testing per ISO 14801.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple tooth prostheses supported by dental implants in the maxilla or mandible.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Replace™ HA Coated Implant (K020646)
• NobelActive Internal Connection Implant (K071370)
• 3i OSSEOTITE Certain® Dental Implants (K063341)
• OSSEOTITE Dental Implants (K063286)
• Various Brånemark System Implants – Immediate Function Indication (K022562)
• P.004 Implants (K062129)
• Straumann Dental Implant System SLActive and Roxoid Product Families (K130222)
• Zimmer Dental Implant System (K061410)
• Astra Tech Implant System (K101732)
• FRIADENT Implant Systems (K073075)

Reference Devices

• ANKYLOS® Dental Implant System (K041509)
• NobelActive Multi-Unit Abutment (K072570)
• Multi-Unit Abutments for Straumann and Astra Tech Implant Systems (K093643)
• Locator Implant Anchor (K072878)
• 2.2 mm Angled Micro ERA Dental Implant System (K092434)
• OsseoSpeed™ Plus (K120414)
• CAMLOG Implant System Modified Implants and Abutments (K083496)
• P.004 RC/NC Bar and Bridge Abutments Line (K080239)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 GmbH<br>Hammweg 8-10<br>76549 Hügelsheim, Germany<br>Telephone [phone]<br>Fax [phone] |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Gerhard Polzer<br>Head of Quality Management / Regulatory Affair |
| Representative/Consultant | Linda K. Schulz<br>Floyd G. Larson<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>[e-mail] |

## 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. ●