ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS

K133255 · Dentalpoint AG · DZE · Aug 12, 2014 · Dental

Device Facts

• Record ID: K133255
• Device Name: ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS
• Applicant: Dentalpoint AG
• Product Code: DZE · Dental
• Decision Date: Aug 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zeramex® T 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® T Dental Implant System can be used for single or multiple unit restorations. Zeramex® T implants are intended for delayed loading. The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies. The Zeramex® T (Ø 3.5 mm) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

Device Story

Zeramex® T is a two-piece endosseous dental implant system; consists of zirconium oxide implants and abutments. Implants surgically placed in upper/lower jaw bone by dentists; provide support for prosthetic devices (artificial teeth). System includes surgical tools (drills, screwdrivers, placement tools) for site preparation and implant insertion. Abutments are bonded to implants using validated dental cements (Panavia, RelyX) and an internal cylindrical connection for anti-rotation/mechanical locking. Implants are intended for delayed loading. Device restores aesthetics and chewing function; specifically benefits patients with metal allergies. Healthcare providers use the system to replace missing teeth; clinical decision-making based on patient anatomy and allergy status.

Clinical Evidence

Single-center, open-label, prospective clinical study of 49 implants in partially edentulous, systemically healthy patients. Two-year cumulative survival rate was 87%. Complication rates: soft-tissue 0%, technical 4%, bone loss >2 mm 0%, aesthetic 0%.

Technological Characteristics

Materials: Zirconia (zirconium oxide). Design: Two-piece implant/abutment system with internal cylindrical connection. Surface: Grit-blasted and acid-etched. Dimensions: Diameters 3.5-5.5 mm; lengths 8-14 mm. Sterilization: Steam (SAL 10^-6). Connectivity: Mechanical lock via cement and anti-rotation feature.

Indications for Use

Indicated for patients requiring dental implants for single or multiple unit restorations to restore aesthetics and chewing function, specifically including patients with metal allergies or chronic illnesses related to metal allergies. The 3.5 mm diameter implant is restricted to anterior lower jaw and lateral upper jaw teeth.

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

• CeraRoot Implant System (K093595)
• Z-Look3 Dental Implant System (K062542)
• Branemark System® (K992937)

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

August 12, 2014

Dentalpoint AG C/O Ms. Roshana Ahmed Regulatory Affairs Manager OptumInsight (Canada) Inc. 4 Innovation Drive Dundas, Ontario L9H7P3 CANADA

Re: K133255

Trade/Device Name: Zeramex® T and Zeramex Plus Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: July 10, 2014 Received: July 14, 2014

Dear Ms. Ahmed:

This letter corrects our substantially equivalent letter of August 12, 2014.

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 Parts 801): medical device reporting (reporting of medical device-related 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, 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" (21CFR 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,

Mary S. Runner -S

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

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# Indications for Use

510(k) Number (if known) K133255

Device Name Zeramex® T Dental Implant System

#### Indications for Use (Describe)

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

Zeramex® T implants are intended for delayed loading.

The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies.

The Zeramex® T (0 3.5 mm) implant may only be used in the lower jaw and lateral teeth in the upper jaw.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

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| B. 510(k) Summary | |
|-------------------|--|
|-------------------|--|

| Manufacturer Name: | Dentalpoint AG |
|--------------------|---------------------------------------------|
| Address: | Hohlstrasse 614<br>Zurich, Switzerland 8048 |
| Contact Name: | Viktor Lienhard |
| Title: | Sales Management |
| Phone Number: | ([phone] |
| Fax Number: | ([phone] |
| Date Prepared: | July 10, 2014 |

| Device Proprietary Name: | Zeramex® T Dental Implant System |
|------------------------------|--------------------------------------|
| Device Common or Usual Name: | Dental Implant Systems |
| Classification Name: | Root-form Endosseous Dental Implants |
| Classification Code: | DZE, NHA |
| Regulation Number: | 872.3640 |

### Predicate Devices:

Substantial equivalence is claimed to the following devices:

| Name of Device | Manufacturer | 510(k)<br>Number |
|-------------------------------|------------------------|------------------|
| CeraRoot Implant System | Oral Iceberg S.L. | K093595 |
| Z-Look3 Dental Implant System | Z-Systems AG | K062542 |
| Branemark System® | Nobel Biocare USA Inc. | K992937 |

### Description of the Device

The Zeramex® T System is an endosseous dental implant/abutment system. The Zeramex® T implants are placed using the Zeramex® T surgical tools. The implants are provided in three diameters (Ø 3.5 mm, 4.2 mm, and 5.5 mm) and three lengths (8 mm, 10 mm, and 12 mm). The Ø 4.2 mm implant is also offered in a 14 mm length. Dentalpoint AG offers several compatible abutments and other accessories including straight and angular (15°) abutments in small, regular/wide, and wide sizes, healing caps, and gingiva formers. The abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex system: Panavia (K032455) and 3M ESPE RelyX (K111185).

Class I, 510(k) exempt accessories are provided in the Zeramex® T tray and include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication or dental prosthetics, and trial abutments. The surgical tools are intended to be reprocessed (cleaned, disinfected, and sterilized) after each procedure.

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# Intended Use/Indications for Use

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

Zeramex® T implants are intended for delayed loading.

The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies.

The Zeramex® T (Ø 3.5 mm) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

# Technological Characteristics

Zeramex® T Dental Implant System has the same intended use as the predicate devices, with implants intended for implantation in the upper and lower jaw in order to restore aesthetics and a patient's chewing function. The two-piece, sterile implants and abutments are manufactured from zirconium oxide. An internal cylindrical connection serves as an anti-rotation feature and mechanically locks the fixtures ensuring form- and force-fit connections. The implants and abutments are provided in similar diameters and lengths as the predicate devices. Implant surfaces are treated via grit blasting and acid etching processes. The Zeramex® abutments are fixed via an adhesive process which affixes the abutment to the implant, and in conjunction with the anti-rotational feature, prevents the abutments from being removed.

A comparison of the subject and predicate devices is provided below.

| | Zeramex® T<br>Dental Implant<br>System | CeraRoot<br>Implant System<br>(K093595) | Z-Look3 Dental<br>Implant System<br>(K062542) | Branemark<br>System® Dental<br>Implants<br>(K992937) |
|---------------------|----------------------------------------|-----------------------------------------|-----------------------------------------------|------------------------------------------------------|
| Manufacturer | Dentalpoint AG | Oral Iceberg S.L. | Z-Systems AG | Nobel Biocare USA, Inc |
| Materials | Zirconia | Zirconia | Zirconia | Titanium |
| Implant<br>Lengths | 8 mm<br>10 mm<br>12 mm<br>14 mm | 8 mm<br>10 mm<br>12 mm<br>14 mm | 10 mm<br>11.5 mm<br>13 mm<br>14 mm | 10 mm – 21 mm |
| Implant<br>Diameter | 3.5 mm<br>4.2 mm<br>5.5 mm | 3.5 mm<br>4.1 mm<br>4.8 mm | 3.25 mm<br>4.0 mm<br>5.0 mm | 3.75 mm<br>4 mm |

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| | | 6.0 mm<br>6.5 mm | | |
|-------------------------------|------------------------------------------|--------------------------|------------------|--------------------|
| Design | Two-piece design | One-piece design | One-piece design | Two-piece design |
| Anti-<br>Rotation<br>Features | Internal cylindrical connection + cement | N/A | N/A | Unknown |
| Surface<br>Treatment | Grit blasted, acid etched | Acid etched | Grit blasted | No surface coating |
| Sterilization | Steam, SAL 10-6 | Ethylene oxide, SAL 10-6 | Steam, SAL 10-6 | Dry heat/ Steam |

# Pre-Clinical Testing

Testing to support the safety and effectiveness of the devices included:

- . Fatigue testing in accordance with ISO 14801
- Surface chemical analysis ●
- Validation of cleaning, disinfection, and sterilization processes .
- Packaging and transport validation .

# Clinical Testing

A single-center, open-label, prospective clinical study was conducted to demonstrate the safety and effectiveness of the Zeramex® T dental implants. Partially edentulous, systemically healthy patients were enrolled in the study. A total of 49 implants spanning the range of offered diameters and lengths were placed in lower and upper jaw. The overall two-year cumulative survival rates 1 and 2 years after loading was 87%. The soft-tissue complication rate was 0%, the technical complication rate was 4%, the complication rate for bone loss greater than 2 mm was 0%, and the aesthetic complication rate was 0%.

# Conclusion

The results of the non-clinical and clinical testing support that the Zeramex® T Dental Implant System is safe and effective. Although minor differences in design and technology exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the Zeramex® T Dental Implant System is substantially equivalent to the predicate devices.