(427 days)
The dental device is composed by two distinguished and physically connected equipments, that are:
- dental chair -
- dental unit (hydro-group)
The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.
The dental device is composed by two distinguished and physically connected equipments, that are:
- dental chair -
- dental unit (hydro-group)
The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.
This appears to be a 510(k) clearance letter from the FDA for medical devices (S200 and S300 Dental Operative Units). This type of document does not typically contain acceptance criteria or detailed study information for device performance as you've requested.
The FDA's 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring performance studies that prove specific acceptance criteria are met for all the parameters you've listed. For Class I devices like these, substantial equivalence is often established through detailed comparisons of technological characteristics, design, materials, and intended use to an existing device, along with verification and validation activities (which are usually summarized in the 510(k) submission but not fully detailed in the clearance letter itself).
Therefore, based on the provided text, I cannot extract the information you've requested about acceptance criteria and specific studies.
Here's why and what kind of information you can find in this document:
- Acceptance Criteria & Device Performance: Not present. The letter states the device is "substantially equivalent" to predicate devices, meaning it has met the regulatory threshold for market clearance, but it doesn't provide performance metrics or acceptance criteria for those metrics.
- Sample size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (training/test sets): This level of detail would be found in the actual 510(k) submission, specifically in sections related to verification and validation testing, and potentially clinical data summaries if a clinical study was deemed necessary (which is less common for Class I devices like these without novel technology). The clearance letter itself does not include this.
- Device Type: Dental Operative Unit and Accessories (S200 and S300 models).
- Regulation Number: 21 CFR 872.6640 (Dental Operative Unit and Accessories).
- Regulatory Class: Class I.
- Product Code: EIA.
- Indication for Use: To support and position the patient during dental operations, and to lodge, support, and functionally supply professional instruments used by the dentist.
- Prescription Use: X (21 CFR Part 801 Subpart D).
To obtain the detailed information you're asking for, you would generally need to access the full 510(k) premarket notification file for K133412, which can be much more extensive than this clearance letter. However, even then, for a Class I device based on substantial equivalence, the type of rigorous, statistically powered performance studies, multi-reader studies, or large-scale clinical trials common for higher-risk or novel AI/CAD devices are typically not required or performed. Performance is usually demonstrated through bench testing, engineering verification, and comparison to the predicate device's established performance characteristics.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8,2015
Cefla s.c. C/O Mr. Claude Berthoin President Thema USA 110 East Granada Boulevard, Suite 207 Ormond Beach, FL 32176
Re: K133412
Trade/Device Name: S200 and S300 Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 8, 2014 Received: December 9, 2014
Dear Mr. Berthoin:
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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Page 2 - Mr. Berthoin
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
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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INDICATION FOR USE
Applicant: CEFLA s.c. - CEFLA DENTAL GROUP
510(k) Number (if known): K133412
Device Name: S200
Indication For Use:
The dental device is composed by two distinguished and physically connected equipments, that are:
- dental chair -
- dental unit (hydro-group)
The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Division Sign-Off Office of Device Evaluation
510(k)
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Applicant: CEFLA s.c. - CEFLA DENTAL GROUP
510(k) Number (if known): K133412
Device Name: S300
Indication For Use:
The dental device is composed by two distinguished and physically connected equipments, that are:
- dental chair -
- dental unit (hydro-group)
The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Division Sign-Off Office of Device Evaluation
510(k)
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.