(25 days)
Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.
The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.
The provided 510(k) summary for the Allure® MB Ceramic Brackets (K090454) is for a dental device, specifically orthodontic brackets. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and material composition, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k)) | Reported Device Performance (from 510(k)) | Notes |
|---|---|---|
| Technological Characteristics: The Allure® MB Ceramic Brackets represent a modification to K852179. | The Allure® MB Ceramic Brackets have a mechanical lock base, which includes rhomboid and "torque-in-the-base" features. This replaces the chemically treated base of the predicate device (Allure, K852179). | The device's performance is not quantified in terms of specific metrics but rather through its technical characteristics and material composition, deemed safe and effective based on predicate devices. |
| Material Composition and Safety: All components have been used in legally marketed devices and/or were found safe for dental use. | Allure® MB Ceramic Brackets are of the same composition as the predicate devices. Therefore, further biocompatibility testing is not necessary. | Safety is established through prior use of components and general biocompatibility data from predicate devices. No specific quantitative performance metrics are provided. |
| Intended Use Equivalence: Substantially equivalent to legally marketed predicate devices. | "We believe that the prior use of the component of Allure® MB Ceramic Brackets in legally marketed devices, the performance data provided, and the previously submitted biocompatibility data each provide support regarding the safety and effectiveness for the indicated uses." | The device is deemed substantially equivalent for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This 510(k) relies on demonstrating substantial equivalence through technical characteristics and material composition, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no clinical study or test set with ground truth was presented in this 510(k) for AI performance.
4. Adjudication method for the test set
- Not Applicable. No test set requiring adjudication for AI performance was presented.
5. 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 is a device modification for an orthodontic bracket, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not Applicable. While the device seeks "substantial equivalence," the "ground truth" in this context is the safety and effectiveness of the predicate devices and their components. This is not derived from expert consensus, pathology, or outcomes data in the way an AI system's performance would be.
8. The sample size for the training set
- Not Applicable. This device did not involve an AI training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used for this type of device submission.
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510(k) SUMMARY for Allure® MB Ceramic Brackets
DENTSPLY Internation
World Headquarters Susquehanna Commerce ( 221 West Philadelphia Sh York, PA 17405-0872 1800) 877-0020 Fax (717) 849-4343 www.dentsply.com
- Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
19 February 2009 Date Prepared:
2.. Device Name:
.
- Proprietary Name: Allure® MB Ceramic Brackets .
- Classification Name:
- Bracker, Ceramic, Orthodontic 872.5470
- Classification Name:
- CFR Number: . Device Class: .
- II NJM Product Code: .
ここ Sponsor's Predicate Device:
| Company | Device | 510(k) Number | Date Cleared |
|---|---|---|---|
| DENTSPLY International | Allure | K852179 | 08/20/1985 |
| DENTSPLY International | Mystique MBCeramic Brackets | K082974 | 11/07/2008 |
Description of Device: 4.
The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.
-
- Indications for Use:
Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.
- Indications for Use:
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- Description of Safety and Substantial Equivalence: 6.
Technological Characteristics. Technological Characteristiss:
The Allure® MB Ceramic Brackets represent a modification to K852179.
All of the components found in Allure® MB Ceramic Brackets have been used in All of the components found in Anares most me safe for dental use. Allure® MB
legally marketed devices and/or were tound safe for dental wissess of therefor legally markets are the same composition as the predicate devices. Therefore, further biocompatibility testing is not necessary.
We believe that the prior use of the component of Allure® MB Ceramic Brackets we believe that the prof use of the componsible , and the provided, and the previously
in legally marketed devices, the performance data provided, and in legally marketed devices, the provide support regarding the safety and submitted blocompationity data each as exceets for the indicated uses.
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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 & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
MAR 2 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K090454
Trade/Device Name: Allure® MB Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: February 19, 2009 Received: February 23, 2009
Dear Ms. Lewis:
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 vour 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 - Ms. Lewis
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); 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Barry
Ginette Y. Michaud, M.D.
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Allure® MB Ceramic Brackets
Indications for Use:
Allure® MB ceramic brackets are indicated for the orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Reusser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K0920454
Allure® MB Ceramic Brackets
§ 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.