The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.

Device Description

The Ceramic System-HexLock uses a titanium hex core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is cemented to the core for a final restoration. The core will be offered in two implant interface diameters, 3.5mm, and 4.5mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

AI/ML Overview

The provided text is a 510(k) summary for the Sulzer Dental Ceramic System-HexLock. It primarily focuses on comparing the new device to predicate devices to establish substantial equivalence, rather than detailing a study with specific acceptance criteria and performance data in the typical sense of a clinical trial or algorithm validation.

However, based on the information provided, we can infer the "acceptance criteria" through the comparison analysis and the "study" demonstrating that the device meets these criteria is the comparison itself, which aims to show substantial equivalence.

Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text for a direct fit:

Acceptance Criteria and Device Performance

The core "acceptance criteria" here is that the Sulzer Dental Ceramic System-HexLock is substantially equivalent to existing, legally marketed predicate devices. The "reported device performance" is demonstrated by the comparison of its technological characteristics and intended use to these predicates.

Key Implicit Acceptance Criterion: Substantial Equivalence to predicate devices (HexLock Abutment (K953101) and FRIALIT®-2 CeraBase Abutment (K980630)).

Feature (Comparison Point)	Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (Sulzer Dental Ceramic System-HexLock)
Intended Use	Primarily Anterior Single-Unit Restoration Cases (FRIALIT®-2 CeraBase Abutment) or broader Anterior/Posterior Single-Unit and Multi-Unit Restoration Cases (Sulzer Dental HexLock Abutment)	Intended for anterior single unit restoration cases. (Stated in 510(k) summary and recognized by FDA in clearance letter). This aligns with the FRIALIT®-2 CeraBase Abutment.
Abutment Body Geometry	Tapered Retentive Wall (specific to the new device, but compared against Straight Retentive Wall of predicates). The acceptance is that this design is similar enough or provides comparable function.	Tapered Retentive Wall
Abutment Diameters	3.5mm & 4.5mm (Sulzer Dental HexLock) and 3.4mm, 3.8mm, 4.5mm, 5.5mm, & 6.5mm (FRIALIT®-2 CeraBase)	4.5mm (as a body diameter) and 3.5mm & 4.5mm for abutment/implant diameter. This falls within the range and specific sizes of the predicate devices.
Abutment/Implant Diameter	3.5mm & 4.5mm (Sulzer Dental HexLock) and 3.4mm, 3.8mm, 4.5mm, 5.5mm, & 6.5mm (FRIALIT®-2 CeraBase)	3.5mm & 4.5mm. This matches the Sulzer Dental HexLock and is covered by the FRIALIT®-2 CeraBase.
Abutment Body Material	Titanium Alloy (Ti-6Al-4V) (Sulzer Dental HexLock) or Pure Titanium grade II (FRIALIT®-2 CeraBase)	Titanium Alloy (Ti-6Al-4V). This is identical to one of the predicate devices.
Implant/Abutment Interface	Hex anti-rotational interface (both predicates)	Hex anti-rotational interface. This is identical to both predicate devices.
Ceramic Coping Material	N/A for Sulzer Dental HexLock; Aluminum Oxide for FRIALIT®-2 CeraBase	Zirconia Toughened Alumina. The document highlights this as a key differentiating feature intended to "improve esthetics." The acceptance criteria implicitly allow for material differences if safety and effectiveness are maintained, likely supported by material testing data (though not detailed here).
Sterility	Sterile (Sulzer Dental HexLock) or Not Sterile (FRIALIT®-2 CeraBase)	Not Sterile. This aligns with one of the predicate devices.
Overall Safety & Effectiveness	Demonstrated by substantial equivalence to predicate devices, ensuring equivalent performance regarding mechanical properties, biocompatibility, and intended clinical outcome.	FDA clearance (K014175) confirms substantial equivalence, implying the device is as safe and effective for its intended use as the predicate devices. This process typically involves demonstrating that any differences do not raise new questions of safety or effectiveness.

Study Details:

It's important to clarify that this document is a 510(k) summary for regulatory clearance, not a research paper detailing a specific clinical study with granular data. The "study" here is implicitly the substantial equivalence comparison performed by the manufacturer and reviewed by the FDA.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a traditional test set for performance parameters. The "test set" is the Sulzer Dental Ceramic System-HexLock itself, and its characteristics are compared against the established characteristics of the predicate devices.
- Data Provenance: The data provenance is from the specifications and characteristics of the new device and the predicate devices (Sulzer Dental HexLock Abutment and FRIALIT®-2 CeraBase Abutment). The manufacturing site for the new device is listed as Carlsbad, CA (USA), and for one predicate as Meinnheim, Germany. This is a retrospective comparison based on existing device specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no "ground truth" expert consensus established for a test set in this 510(k) summary. The ground truth for the predicate devices' safety and effectiveness was established when they received their own regulatory clearances. For the new device, its specifications are provided by the manufacturer.
Adjudication method for the test set:
- Not applicable. The process is a regulatory review by the FDA (specifically the Division of Dental, Infection Control and General Hospital Devices), comparing the new device's documentation to predicate devices. It is not an adjudication based on multiple expert opinions on a specific test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dental implant abutment and ceramic coping system, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used:
- The "ground truth" in this context refers to the established safety, effectiveness, and regulatory clearance of the predicate devices based on their inherent characteristics, testing, and clinical track record. The new device's ground truth for approval is its "substantial equivalence" to these predicates. This involves comparing engineering specifications, materials, and intended use, likely supported by bench testing (though not detailed in the summary).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

Summary

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MAR 2 0 2002

510(K) Summary

K014175

Pursuant to 510 (i) of the Federal Food, Drug, and Cosmetic Act, as Amended.

Company Name: Sulzer Dental Inc. Address: 1900 Aston Avenue, Carlsbad, CA 92008-7308 Telephone Number: 760-929-4300 Registration Number : 2023141 Contact Person: Sean Hariri Date Summary Prepared: December 19, 2001 Classification Name: Endosseous Dental Implant Common/Usual Name: Abutment for Dental Implant System Device Trade Name: Sulzer Dental Ceramic System-HexLock

The device used for comparison in this summary is the HexLock Abutment (K953101) and the FRIALIT®-2 CeraBase Abutment (K980630) 1. Intended Use:

The Sulzer Dental Ceramic System-HexLock is intended for anterior single unit restoration cases.

2. Description:

3. Technological Characteristics:

The Ceramic System-HexLock is an additional abutment design for Internal Hexagon implant systems. The system consists of two parts, the titanium alloy abutment and the ceramic coping. The abutment will be fixed to the implant with a titanium alloy screw. The ceramic coping will be bonded with porcelain by the laboratory to fabricate the finalized coping. The finished restoration is then cemented to the abutment.

4. Comparison Analysis:

The abutment of the Ceramic System-HexLock is similar to the Sulzer Dental HexLock abutment and the FRIALIT@-2 CeraBase Abutment. The ceramic coping of the Ceramic System is similar to commercial crowns used to fabricate a restoration. See Table 1 below for a comparison of the Ceramic System and the predicate systems.

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Sulzer Dental Ceramic System-HexLock

Feature	Sulzer DentalCeramic System-HexLock	Predicate: SulzerDental HexLockAbutment	Predicate:FRIALIT-2®CeraBaseAbutment
Intended Use	Anterior SingleUnit RestorationCases	Anterior/PosteriorSingle-Unit andMulti-UnitRestoration Cases	Anterior SingleUnit RestorationCases
Abutment BodyGeometry	Tapered RetentiveWall	Straight RetentiveWall	StraightRetentiveWall
Abutment Diameters	4.5mm	3.5mm & 4.5mm	3.4mm, 3.8mm,4.5mm, 5.5mm,& 6.5mm
Abutment/ImplantDiameter	3.5mm & 4.5mm	3.5mm & 4.5mm	3.4mm, 3.8mm,4.5mm, 5.5mm,& 6.5mm
Abutment BodyMaterial	Titanium Alloy(Ti-6Al-4V)	Titanium Alloy (Ti-6Al-4V)	Pure Titaniumgrade II
Implant/AbutmentInterface	Hex anti-rotationalinterface	Hex anti-rotationalinterface	Hex anti-rotationalinterface
Ceramic CopingMaterial	ZirconiaToughenedAlumina	N/A	Aluminum Oxide
Manufacturing Site	Carlsbad, CA	Carlsbad, CA	Meinnheim,Germany
Packaging	PETG tray andTyvek® lid	Two Vial System	Blister packcombined w/cardboard outerwrap.
Sterile	No	Yes	No

Table: 1 Summary of Comparison

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird-like figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

Mr. Sean Hariri Regulatory Affairs Associate Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad. California 92008-7308

Re: K014175

Trade/Device Name: Sulzer Dental Ceramic System-Hexlock Regulation Number: 872.3640 Regulation Name: Abutment For Dental Implant System Regulatory Class: III Product Code: NHA Dated: December 19, 2001 Received: December 20, 2001

Dear Mr Hariri:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Hariri

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Suarez

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: _Sulzer Dental Ceramic System-HexLock

Indications for Use: The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use_

(Optional Format 1-2-96)

Suger Rung

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division oal Hospital Devices Clu > 510(k) Number

Regulation Number and Section

§ 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.)