(126 days)
Not Found
No
The summary describes a standard dental handpiece and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is used for mechanical dental procedures like removing carious material and polishing teeth. While these procedures are part of dental care, the device itself doesn't directly treat a disease or condition in a therapeutic sense; rather, it's a tool for performing a procedure.
No
The device is described as a handpiece for removing carious material, preparing and finishing tooth structures, and polishing teeth, which are all treatment procedures, not diagnostic ones.
No
The device description explicitly states "Dental Air-Powered Handpiece," which is a hardware device. The summary does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for mechanical procedures on teeth (removing material, preparing cavities, finishing, polishing). This is a direct physical intervention on the patient's body.
- Device Description: It's a "Dental Air-Powered Handpiece," which is a tool used for physical manipulation.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens in vitro (outside the body) to provide information about a patient's health.
This device is a surgical/dental instrument used for treatment, not for diagnosis based on in vitro testing.
N/A
Intended Use / Indications for Use
The CODENT Dental Air-Powered Handpiece is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Product codes
EFB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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.
0
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.
1
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)
2
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.
3
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
4
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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