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 Description

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Zeramex® T Dental Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical study endpoints. However, it does report the device performance for key safety and effectiveness measures. The "acceptance criteria" listed below are inferred as the performance observed in the study.

Acceptance Criteria (Inferred)	Reported Device Performance
Minimum 2-year cumulative survival rate for implants	87%
Maximum soft-tissue complication rate	0%
Maximum technical complication rate	4%
Maximum complication rate for bone loss greater than 2 mm	0%
Maximum aesthetic complication rate	0%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 49 implants
Data Provenance:
- Country of Origin: Not explicitly stated, but the manufacturer is Dentalpoint AG, located in Zurich, Switzerland. The clinical study was a "single-center" study.
- Retrospective or Prospective: Prospective

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical study. The "ground truth" for the clinical study would likely be the direct clinical observation and measurements by the treating clinicians and study staff.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set (clinical study). Outcomes were presumably assessed by the clinical site directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The clinical study described is a single-arm study evaluating the device's performance, not comparing it against human readers or other devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The Zeramex® T Dental Implant System is a physical medical device (dental implant), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the clinical study, the ground truth was based on:

Outcomes data: Specifically, implant survival rates, and reported complication rates (soft-tissue, technical, bone loss, aesthetic). These are direct measures from the patients and their clinical follow-ups.

8. The Sample Size for the Training Set

This question is not applicable. The Zeramex® T Dental Implant System is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device involves engineering design, material science, and manufacturing processes, supported by pre-clinical testing, rather than data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" in the context of an AI/ML algorithm. The development of the device involves pre-clinical testing:

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

The "ground truth" for these pre-clinical tests would be the established scientific standards, protocols, and measurable outcomes (e.g., meeting specific force thresholds in fatigue testing, chemical composition analysis results, sterility assurance levels).

Summary

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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 (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" (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 (800) 638-2041 or (301) 796-7100 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 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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B. 510(k) Summary
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Manufacturer Name:	Dentalpoint AG
Address:	Hohlstrasse 614Zurich, Switzerland 8048
Contact Name:	Viktor Lienhard
Title:	Sales Management
Phone Number:	(+41) 44 388 36 36
Fax Number:	(+41) 44 388 36 39
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)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

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Intended Use/Indications for Use

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® TDental ImplantSystem	CeraRootImplant System(K093595)	Z-Look3 DentalImplant System(K062542)	BranemarkSystem® DentalImplants(K992937)
Manufacturer	Dentalpoint AG	Oral Iceberg S.L.	Z-Systems AG	Nobel Biocare USA, Inc
Materials	Zirconia	Zirconia	Zirconia	Titanium
ImplantLengths	8 mm10 mm12 mm14 mm	8 mm10 mm12 mm14 mm	10 mm11.5 mm13 mm14 mm	10 mm – 21 mm
ImplantDiameter	3.5 mm4.2 mm5.5 mm	3.5 mm4.1 mm4.8 mm	3.25 mm4.0 mm5.0 mm	3.75 mm4 mm

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		6.0 mm6.5 mm
Design	Two-piece design	One-piece design	One-piece design	Two-piece design
Anti-RotationFeatures	Internal cylindrical connection + cement	N/A	N/A	Unknown
SurfaceTreatment	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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.