TRUKLEAR BRACKET

• K Number: K141104
• Device Name: TRUKLEAR BRACKET
• Manufacturer: AJW TECHNOLOGY CONSULTANTS, INC.
• Date Cleared: 2014-06-25 ( 57 days)
• Product Code: NJM
• Regulation Number: 872.5470

Intended Use

The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

Device Description

The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted, to alter the tooth position. The force is introduced by a flexible orthodontic wire, which is attached to Orthodontic Ceramic Brackets. The ceramic bracket has both, aesthetic and self ligating qualities. The bracket design enables easier orthodontic wire placement and removal through self-ligating properties.

Predicate Devices

K090933

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical orthodontic bracket and its mechanical and biocompatibility testing, with no mention of AI or ML.

Therapeutic

Yes
The device is used to apply forces to teeth to alter their position as part of orthodontic treatment, which is a therapeutic intervention.

Diagnostic

No
The device, orthodontic ceramic brackets, is used to apply force to teeth for movement, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical "Orthodontic Ceramic Brackets" that are bonded to teeth and interact with a wire. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "orthodontic movement of teeth." This is a mechanical function performed directly on the patient's teeth.
• Device Description: The description details how the brackets are bonded to teeth and apply force via a wire to alter tooth position. This is a physical intervention.
• Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

"This device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only."

Product codes (comma separated list FDA assigned to the subject device)

NJM

Device Description

"The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted, to alter the tooth position. The force is introduced by a flexible orthodontic wire, which is attached to Orthodontic Ceramic Brackets. The ceramic bracket has both, aesthetic and self ligating qualities. The bracket design enables easier orthodontic wire placement and removal through self-ligating properties."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The TruKlear bracket underwent bench testing according to several different performance standards: Material Strength (Din EN ISO 27020), Slider Mechanism (Din EN ISO 27020), and Bonding Test (DIN 13990-2).
Biocompatibility testing was also completed, including:

1. Acute Systemic Toxicity in Mouse according to ISO 10993-1: 2009, ISO 10993-11: 2006, ISO 10993-12:2012.
2. Cytotoxicity Growth Inhibition Test according to ISO 10993-5, ISO 10993-12.
3. Extractable Organic Substances after Liquid Extraction according to ISO 10993-18 and ISO 10993-12.
4. Irritation Test according to ISO 10993-1: 2009. ISO 10993-10: 2010. and ISO 10993-12: 2012.
5. Reverse Mutation Assay according to ISO 10993-1: 2009, ISO 10993-3: 2003, and ISO 10993-12: 2012.
6. Delayed Type Hypersensitivity Nonpolar Extract according to ISO 10993-1: 2009, ISO 10993-10: 2010, and ISO 10993-12: 2012.
7. Delayed Type Hypersensitivity Polar Extract according to ISO 10993-1: 2009. ISO 10993-10: 2010 and ISO 10993-12: 2012.
   Key results: "Based on the conclusions of each of these tests it is determined that the TruKlear bracket demonstrates that the device is substantially equivalent to the predicate device."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K090933

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.

Summary

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JUN 2 5 2014

510(k) SUMMARY (as required by 807.92(c))

| Regulatory Correspondent: | AJW Technology Consultants Inc.
445 Apollo Beach Blvd
Apollo Beach, FL 33572
Contact: Tanya O'Brien
[e-mail]
813-645-2855 x 102
813-645-2856 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Bernhard Forster GmbH
Westliche Karl - Friedrichstraße 151
75172 Pforzheim, Germany
Contact: Michael Fiess
[e-mail]
Telephone: [phone]
Fax: [phone] |
| Date of Summary: | June 17, 2014 |
| Trade/Proprietary Name: | TruKlear Orthodontic Ceramic Brackets |
| Common Name: | Bracket, Ceramic, Orthodontic |
| Classification Name: | Orthodontic Ceramic Bracket |
| Device Class: | II |
| Regulation Number: | 872.5470 |
| Device Panel: | Dental |
| Product Code: | NJM |

Intended Use:

.

.

This device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

. .

1

Device Description:

The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted, to alter the tooth position. The force is introduced by a flexible orthodontic wire, which is attached to Orthodontic Ceramic Brackets. The ceramic bracket has both, aesthetic and self ligating qualities. The bracket design enables easier orthodontic wire placement and removal through self-ligating properties.

The function and performance of the orthodontic ceramic brackets are equal to the predicate device.

The material was selected according the requirements of ISO 6474:1994. Ceramic materials are based on High purity aluminia.

Substantial Equivalence:

The Orthodontic Ceramic Brackets are substantial equivalent in intended use and similar technological characteristics to the:

Orthodontic Ceramic Brackets (K090933) for the orthodontic movement of teeth to alter tooth position.

| Applicant
and Device
Name | Forestadent Bernhard
Forster GmbH
Orthodontic Ceramic
brackets
TruKlear | Forestadent Bernhard Forster
GmbH
Orthodontic Ceramic brackets
Quicklear |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) -
Number | This submission | (K090933) |
| Device
classification
name | Orthodontic Ceramic
Bracket CFR 872.5470,
NJM | Orthodontic Ceramic bracket
CFR 872.5470; NJM |
| Material | AL2O3
mechanism plastic material | AL2O3 |
| Intended use | The device is intended for
orthodontic movement of
teeth. It is used temporarily
and is removed after
orthodontic treatment has
been completed. The devices
are intended to be single
used only. | The device is intended for
orthodontic movement of
teeth. It is used temporarily
and is removed after
orthodontic treatment has
been completed. The devices
are intended to be single used
only. |
| Single use | Single Use | Single Use |
| Sterility | Non-sterile | Non-sterile |
| Method of
tooth adhesion | Bonding to tooth | Bonding to tooth |

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| Method of
tooth

movement	Application of force through orthodontic wire	Application of force through orthodontic wire
Performance	Self-ligating, aesthetic ceramic bracket	Self-ligating, aesthetic ceramic bracket
Slide
mechanism	Ceramic slide mechanism	Metallic clip

Rational for Substantial Equivalence:

The testing completed in the previously cleared submissions along with the additional testing completed demonstrates that the new TruKlear bracket exhibits comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible acceptable. Based on those characteristics, the Forestadent Bernhard-Forster TruKlear bracket is substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

Summary of Non-Clinical Data:

The TruKlear bracket underwent bench testing according to several different performance standards. Below is a chart of the different testing that was completed.

Device.	Performance Test	Standard of Compliance
TruKlear Bracket	Material Strength	Din EN ISO 27020
TruKlear Bracket	Slider Mechanism	Din EN ISO 27020
TruKlear Bracket	Bonding Test	DIN 13990-2

Summary of Biocompatibility Testing:

The TruKlear bracket underwent biocompatibility testing according to several different performance standards. Below is a list of the different testing that was completed:

• 1. Acute Systemic Toxicity in Mouse according to ISO 10993-1: 2009, ISO 10993-11: 2006, ISO 10993-12:2012.
• 2. Cytotoxicity Growth Inhibition Test according to ISO 10993-5, ISO 10993-12.
• 3. Extractable Organic Substances after Liquid Extraction according to ISO 10993-18 and ISO 10993-12.
• 4. Irritation Test according to ISO 10993-1: 2009. ISO 10993-10: 2010. and ISO 10993-12: 2012.
• 5. Reverse Mutation Assay according to ISO 10993-1: 2009, ISO 10993-3: 2003, and ISO 10993-12: 2012.
• 6. Delayed Type Hypersensitivity Nonpolar Extract according to ISO 10993-1: 2009, ISO 10993-10: 2010, and ISO 10993-12: 2012.
• 7. Delayed Type Hypersensitivity Polar Extract according to ISO 10993-1: 2009. ISO 10993-10: 2010 and ISO 10993-12: 2012.

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Conclusion

Based on the conclusions of each of these tests it is determined that the TruKlear bracket demonstrates that the device is substantially equivalent to the predicate device.

4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 25, 2014

Bernhard Forster GmbH c/o Ms. Tanya O'Brien RN/BSN/CPAN AWJ Technology Consultants, Inc. 445 Apollo Beach Boulevard Apollo Beach, FL 33572

Re: K141104

Trade/Device Name: TruKlear Orthodontic Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Bracket, Ceramic, Orthodontic Regulatory Class: II Product Code: NJM Dated: May 21, 2014 Received: May 27, 2014

Dear Ms. O'Brien:

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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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

Enclosure

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Indications for Use

510(k) Number (if known): K141104

Device Name: Orthodontic Ceramic Bracket

Indications For Use: The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

and the comments of the comments of the comments of the comments of

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .

・

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Sheena A. Green -S 2014.06.23 09:49:25 -04'00'

Bernhard Forster GmbH TruKlear Special 510(k)

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