(72 days)
Flexitime Light Flow/Flexitime Medium Flow each is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.
Dental Impression Material
The provided text is related to a 510(k) premarket notification for a dental impression material (Flexitime Light Flow / Medium Flow). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with acceptance criteria and device performance in the manner typically associated with clinical trials or AI/software validation.
Therefore, the requested information elements (1-9) which pertain to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, and AI performance metrics are not applicable to this 510(k) submission.
The document states:
- "No performance standards have been established for this type of device."
- "The results of device performance testing demonstrated that it is suitable for use as an impression material, Flexitime Flow has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices."
This indicates that the focus was on demonstrating that the new device performs similarly to existing, approved devices, rather than meeting specific quantifiable performance criteria through a rigorous study as described in your request. Comparisons would typically involve physical and chemical properties relevant to dental impressions, but the details of such tests are not provided in this excerpt.
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Heraeus Kulzer, LLC Product Name: Flexitime Light Flow / Medium Flow 510(k) Pre-Market Notification Submission
GENERAL INFORMATION
May 12, 2009
Cheryl V. Zimmerman Submitter: 300 Heraeus Wav South Bend, Indiana 46614
JUL 8 1 2009
Telephone No.: 574-299-5444
Date:
574-291-2542 Fax No .:
Submitter's Company Establishment Number: 1925223
Submitter's Company Name: Heraeus Kulzer, LLC
Device Trade Name: Flexitime Flow
Device Common Name: Dental Impression Material
Original 510(k) No.: Not Applicable
Manufacturer: Heraeus Kulzer. GmbH Hanau, Germany
Device Classification: Class II - Dental Impression Material. 21 CFR Part 872.3660
Device Product Code: 76ELW
Reason for Submission: This submission is being made to request approval to market Flexitime Flow.
Statement of Substantial Equivalence: Flexitime Light Flow /Medium Flow is equivalent to Flexitme Magnum 360 K000629 and K003930.
Compliance with requirements of Performance Standards: No performance standards have been established for this type of device. The results of device performance testing demonstrated that it is suitable for use as an impression material, Flexitime Flow has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
BOOZ I 8 THET
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl V. Zimmerman Manager. Quality Operations and Compliance Heraeus Kulzer, Incorporated 300 Heraeus Way South Bend, Indiana 46614
Re: K091494
Trade/Device Name: Flexitime Light Flow and Flexitime Medium Flow Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 15, 2009 Received: May 20, 2009
Dear Ms. Zimmerman:
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- Ms. Zimmerman
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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 Runner
Susan Runner, D.D.S., M.A. Acting Division 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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Page 1 of 1
510(k) Number (if Known):
Device Name: Flexitime Light Flow / Medium Flow
Indications For Use:
Flexitime Light Flow/Flexitime Medium Flow each is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | V |
|---|---|
| OR | Over-The-Counter Use |
| (Division Sign-Off) | Rin Mulby for MSR (Optional Format 1-2-96) |
|---|---|
| Division of Anesthesiology, General HospitalInfection Control, Dental Devices | |
| 510(k) Number: | R091494 |
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).