Zeramex P6 Dental Implant System

K163043 · Dentalpoint AG · DZE · Nov 30, 2016 · Dental

Device Facts

• Record ID: K163043
• Device Name: Zeramex P6 Dental Implant System
• Applicant: Dentalpoint AG
• Product Code: DZE · Dental
• Decision Date: Nov 30, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations. The Zeramex® P6 implants are intended for delayed loading. The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances. The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the lower jaw and lateral incisor in the upper jaw.

Device Story

Endosseous dental implant system; includes implants, abutments, and accessories. Implants placed surgically in upper/lower jaw bone; provide support for prosthetic devices (artificial teeth) to restore aesthetics/chewing function. Implants made of aluminum toughened zirconia (ATZ); abutments made of ATZ or PEEK-Optima™ Ultra; screws made of carbon fiber reinforced PEEK. System features internal cylindrical connections; anti-rotational features (triangular/hexagonal). Used by dentists/oral surgeons in clinical settings. Implants intended for delayed loading. Output is a stable base for prosthetic restoration. Benefits patients with metal allergies/intolerances by providing metal-free implant solution.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by performance data (sterilization, shelf-life, biocompatibility, mechanical testing) from predicate K152385.

Technological Characteristics

Endosseous two-piece dental implant system. Materials: Aluminum toughened zirconia (ATZ) for implants/abutments; PEEK and carbon fiber reinforced PEEK for screws, healing caps, and provisional components. Connection: Internal cylindrical with anti-rotational triangular/hexagonal features. Dimensions: Diameters 3.3mm, 4.1mm, 4.8mm; lengths 8mm, 10mm, 12mm. Sterilization: Validated methods per predicate.

Indications for Use

Indicated for patients requiring dental implants for single or multiple unit restorations to support prosthetic devices in the upper or lower jaw. Specifically indicated for patients with metal allergies/intolerances or chronic illness due to metal allergies/intolerances. The Ø3.3mm SN implant is restricted to the lower jaw and lateral incisor in the upper jaw.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Zeramex® P6 Dental Implant System (K152385)

Reference Devices

• Panavia (K032455)
• 3M ESPE RelyX (K111185)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 30, 2016

Dentalpoint AG % Roshana Ahmed, MA, RAC Senior Manager, Regulatory Affairs - Medical Devices Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

Re: K163043

Trade/Device Name: Zeramex® P6 Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 28, 2016 Received: October 31, 2016

Dear Roshana Ahmed:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

# Michael J. Ryan -S

for 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)

K163043

Device Name

Zeramex® P6 Dental Implant System

### Indications for Use (Describe)

The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.

The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.

The Zeramex® P6 implants are intended for delayed loading.

The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the lower jaw and lateral incisor in the upper jaw.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 3.0 510(k) Summary

#### I. Submitter

Dentalpoint AG Hohlstrasse 614 Zurich, Switzerland 8048

Phone: [phone] Fax: [phone]

Contact Person: Viktor Lienhard, COO Date Prepared: November 29, 2016

#### II. Device

| Device Proprietary Name: | Zeramex® P6 Dental Implant System |
|--------------------------|-----------------------------------|
| Common or Usual Name: | Dental Implant System |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR 872.3640 |
| Product Code: | DZE, NHA |
| Device Classification | 2 |

#### Predicate Device III.

Substantial equivalence is claimed to the following devices:

Primary Predicate:

- Zeramex® P6 Dental Implant System, K152385, Dentalpoint AG
#### Device Description IV.

The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.

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The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm, 4.1 mm, and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.

Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN; 4.0mm) and regular neck (RN, 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.

The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.

The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.

Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.

The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).

The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) VICARBO screws (made of PEEK-Optima™ Ultra (Endolign)), which are provided as straight and angular screws in SN and RN sizes.

Healing caps and gingivaformers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingivaformers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.

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A closure screw (Ø3.5 mm) may be used in lieu of the healing cap to allow the gingiva to cover the platform during the healing period. This component is manufactured from PEEK.

#### V. Indications for Use

The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.

The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.

The Zeramex® P6 implants are intended for delayed loading.

The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw.

#### Comparison of Technological Characteristics VI.

The subject device differs from the predicate device as follows:

- 1. Addition of closure screw
- 2. Administrative updates to the User Manual
- 3. Addition of contraindications to the User Manual and IFU
- 4. Addition of Indication for Use word revision.

The subject and predicate systems include the same components with the exception of the new closure screw, which may be used in lieu of a healing cap. The closure screw is manufactured from the same materials and is subject to the same sterilization methods and parameters as the currently cleared healing caps and gingivaformers. Risk assessment demonstrated that there were no new or revised risks related to the use of the closure screw.

The indications for use statement has been slightly revised to clarify that the Ø3.3mm SN implant should be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw. The words "lateral incisor" replaces the words "lateral teeth". This revision does not alter the intended use of the product.

The administrative changes throughout User Manual seek to clarify verbiage to facilitate use of the system in clinical practice; there is no change in the actual instructions for use or

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surgical technique from the predicate device. The additional contraindications are consistent with the clinical standard of care and are not due to any adverse events.

These changes do not impact the Substantial Equivalence of the product as they do not impact the intended use of the product and technological characteristics are similar to the predicate device.

#### Performance Data VII.

New performance data is not required in support of this submission.

The sterilization validation, shelf-life studies, biocompatibility studies, mechanical testing, and clinical studies from K152385 are applicable to this submission. LAL lot release testing was conducted and reviewed under K152385.

## VIII. Conclusion

There have been no significant changes to the design of the Zeramex® P6 Dental Implant System components since clearance under K152385. The indications for use statement has been slightly revised to clarify that the Ø3.3mm SN implant should be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw. This revision does not alter the intended use of the product. Furthermore, additional contraindications have been added to the labeling in line with clinical practice and industry standards.

As demonstrated by risk analysis, the provision of a closure screw for use in lieu of a healing cap does not suggest new uses of the device.

Therefore, it is concluded that the Zeramex® P6 Dental Implant System is substantially equivalent to the predicate devices.

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