(64 days)
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 Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation. 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 based on High purity aluminia.
This medical device submission for the Bernhard Forster GmbH Orthodontic Ceramic Brackets is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics.
Therefore, the requested information cannot be fully provided in the format of a typical performance study. Instead, the "study" demonstrating acceptance is the comparison to the predicate device and the material testing conducted.
Here's how the provided information aligns with your request:
Acceptance Criteria and Device Performance (in the context of a 510(k) submission)
For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing legally marketed device. Performance is primarily assessed through comparison.
Table of Acceptance Criteria and Reported Device Performance (based on substantial equivalence):
| Acceptance Criteria Category (Implicit in 510(k)) | Predicate Device Performance (Innovation C, K060837) | Bernhard Forster GmbH Device Performance (Orthodontic Ceramic Brackets) |
|---|---|---|
| Intended Use Equivalence | Intended for orthodontic movement of natural teeth. | Intended for orthodontic movement of teeth. Used temporarily and removed after orthodontic treatment. Single-use only. (Slightly broader, but determined substantially equivalent) |
| Material Equivalence | A12O3 | A12O3 (High purity alumina) |
| Design/Function Equivalence | Applies forces to teeth via orthodontic wire. Aesthetic and self-ligating qualities. | Applies forces to teeth via orthodontic wire. Aesthetic and self-ligating qualities facilitating easier wire placement/removal. Function and performance are equal to predicate device. |
| Single Use | YES | YES |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility/Safety | (Implicitly safe and effective due to prior marketing) | Material selected according to ISO 6474;1994 (Ceramic materials based on High purity alumina), implying meeting material safety standards. |
Detailed Breakdown of Study Information (as requested):
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A table of acceptance criteria and the reported device performance
- See table above. The "acceptance criteria" for a 510(k) are essentially demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the direct comparison point-by-point to the predicate device.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This is not a traditional "test set" study. The submission relies on material testing data for the device itself and comparison to the predicate device's established performance.
- Sample Size: Not explicitly stated as a clinical "test set" sample size. The material testing would involve specific numbers of brackets or material samples as per ISO 6474;1994, but these details are not provided in this summary.
- Data Provenance: The manufacturing company is Bernhard Forster GmbH, based in Pforzheim, Germany. Material testing would typically be conducted by the manufacturer or a certified lab. This would be considered "prospective" data for the new device's material properties, but it's not clinical human data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not a study requiring expert readers or "ground truth" establishment in the sense of diagnostic accuracy. The "ground truth" for material properties is established by adherence to recognized international standards (ISO 6474;1994). The "ground truth" for substantial equivalence is the predicate device's established regulatory status and performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "adjudication method" as this is not a diagnostic performance study involving multiple readers.
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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 an orthodontic bracket, not an AI-powered diagnostic tool. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" (or basis of evidence) used for this 510(k) submission is:
- Predicate Device Equivalence: The legally marketed predicate device (Innovation C, K060837) serves as the primary "ground truth" for safety and effectiveness.
- Material Standards: Adherence to international material standards (ISO 6474;1994 for Ceramic materials based on High purity alumina) serves as "ground truth" for the material properties and biocompatibility.
- The "ground truth" (or basis of evidence) used for this 510(k) submission is:
-
The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI device.
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133
JUN - 5 2009
Page 12
510(k) Summary of Safety & Effectiveness
in accordance with requirements 21 CFR 807.92.
1. Company
Bernhard Forster GmbH Westliche Karl- Friedrichstraße 151 75172 Pforzheim - Germany
| Telephone: | 049-7231-459-0 |
|---|---|
| Fax: | 049-7231-459-102 |
| Contact: | Michael Fieß |
2. Device
Orthodontic Ceramic Brackets Proprietary - trade name : Bracket, Ceramic, Orthodontic, product code NJM Classification name:
3. Equivalent legally marketed devices:
Orthodontic Ceramic Bracket Innovation C (K060837), Dentsply International
4. Indication for use:
The device is intended for orthodontic movement of theth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
5. Description of the device
The Orthodontic Ceramic Brackets are bonded to tecth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation
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 based on High purity aluminia.
| Device name | In- Ovation CDentsply | Bernhard Forster GmbHOrthodontic Ceramic brackets |
|---|---|---|
| Deviceclassificationname | Orthodontic Ceramic BracketCFR 872.5470, NJM | Orthodontic Ceramic bracket CFR 872.5470; NJM |
| Applicant | Dentsply International | Bernhard Forster GmbH |
| 510(k) - Number | (K060837) | This submission |
| Material | A1203 | ALSO3 |
| Intended use | The innovation C is intendedfor orthodontic movement ofnatural teeth , excluding themandibular bicuspid teeth . | The device is intended for orthodontic movement of teeth.It is used temporarily and is removed after orthodontictreatment has been completed. The devices are intended tobe single used only. |
| Single use? | YES | YES |
| Sterility | Non-sterile | Non-sterile |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.
Public Health Service
JUN - 5 2009
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Fieb Regulatory Affairs Manager Forestadent Bernhard Förster GmbH Westliche Karl- Friedrich-Straße 151 75172 Pforzheim GERMANY
Re: K090933
Trade/Device Name: Orthodontic Ceramic Brackets Regulation Number: 21.CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: March 31, 2009 Received: April 2, 2009
Dear Mr. Fieb:
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 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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Page 2- Mr. Fieb
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 (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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Penney
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number (if known):
Device Name: Orthodontic Ceramic Brackets
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 to be single used only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lei Mulvey for MSR
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090933
§ 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.