(126 days)
CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Dental Air-Powered Handpiece
The provided text is for a 510(k) premarket notification for a dental air-powered handpiece. This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with proving performance against specific acceptance criteria in a study format typically seen for advanced diagnostic devices or AI algorithms.
Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth definitions) are not applicable or extractable from this document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion for a 510(k) submission like this is "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states: "The claim of substantial equivalence is based on comparisons of formulations and intended uses of the HPS Dental Air-Powered Handpiece and its claimed predicate." No specific performance data (e.g., rotational speed, torque, vibration levels) or clinical outcomes are provided for the CODENT device or its predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/available. This document does not detail a study involving test sets of data. It's a review of device design and intended use for substantial equivalence.
3. 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/available. No such ground truth establishment is described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/available.
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/available. This device is a dental handpiece, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/available. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/available. The "ground truth" for this submission is whether the device's design, materials, and intended use are comparable to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable/available.
9. How the ground truth for the training set was established
- Not applicable/available.
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5. 510(K) SUMMARY
FEB - 6 2004
CONDENT Dental Air-Powered Handpiece Models: HPS
510K: CODENT Technical Industry Co., Ltd. Submitted by: 6F-8, No.7, Wu-Chuan 1st Road, Wu-Ku Industrial Park, Hsin Chuang City, Taipei, 242, Taiwan Dr. Jen. Ke-Min Contact person: No.58, Fu-Chiun Street, Hsin-Chu City,Taiwan, ROC fax: 886-3-5209783 Tel: 8136-3-5208829 E-mail: ceirs jen@msa.hinet.net September 27, 2003 Date Summary Prepared: Name of the Device: Dental Air-Powered Handpiece Dental Air-Powered Handpiece ( class I medical Classification: device; 21 CFR 872.4200 ) Procuct code: EFB Panel: 72 MICRO MOTORS RSH High Speed Handpiece Predicate Device: 510K. No -- K935676 The CODENT Dental Air- Powered Handpiece is Statement of Intended Use: intended for removing escious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. CAUTION: Federal (US) haw restricts the use of this device to licensed professionals.
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The claim of substantial equivalence is based on Performance Data: comparisons of formulations and intended uses of the HPS Dental Air-Powered Handpiece and its claimed predicate.
:
Conclusion:
Based on the information in the notification CODENT believes that Dental Air-Powered Handpiece HPS is substantially equivalent to the claimed predicate, i.e., MICRO MOTORS RSil High Speed Handpiece (K935676)
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three wavy lines representing its body and wings, symbolizing the department's mission to protect and enhance the health and well-being of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB = 6 2004
Codent Technical Industry Company Limited C/O Dr. Jen, Ke-Min Ph.D. Official Correspondent Dr. Jen Ke-Min No.58, Fu- Chiun Street, Hsin- Chu City, TAIWAN, ROC
Re: K033213
Trade/Device Name: CODENT Dental Air- powdered Handpiece, Model HPS Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 18, 2003 Received: December 30, 2003
Dear Dr. Ke-Min:
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, thereforc, 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 adultcration.
If your device is classified (sec 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, I'DA may publish further announcements concerning your device in the Ecderal Register.
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Page 2 –Dr. . Ke-Min
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 mean that I DT mas made a statutes and regulations administered by other Federal agencies. of the Act of ally i ederal states and registments, including, but not limited to: registration 1 our must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), lateling (QS) regulation (21 CFR Part 820); and if requirements as so form in the quadiation 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) IThis letter will anon your copa finding of substantial equivalence of your device to a premarket nothrounom. - 11 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), If you desire specific at no Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral information on your responsibilities under the Act from the may obtain 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,
Quls
Chiu Lin, Ph.D. 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
| 510(k) Number (if known): | K033213 |
|---|---|
| --------------------------- | --------- |
Device Name: CODENT Dental Air-Powered Handpiece, model HPS
Indications for Use:
- CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious � CODENT Delucing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
- CODENT Dental Air-Powered Handpiece carries the following label: . CAUTION: Federal (US)) law restricts the use of this device to licensed professionals.
AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
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)
Susan Ruan
on of Anesthesin Infection Controi Dent
510(k) Number: K033213
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§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.