(120 days)
Not Found
No
The device is an impression material, a physical substance used to create a mold. The description focuses on its chemical composition, physical properties, and compatibility with dental scanners, with no mention of computational processing or algorithms.
No
This device is an impression material used to take dental impressions for crowns, bridges, and other dental work. It is a diagnostic aid, not a device that directly treats a condition or provides therapy.
No
Explanation: The device is an impression material used to create molds for dental restorations, not to diagnose a medical condition or disease. While the impression can be scanned, the material itself does not provide diagnostic information.
No
The device description clearly states it is an "addition-cross-linking polyvinyl siloxane impression material," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental impressions for various restorative and prosthetic procedures. This is a physical process of capturing the shape of the mouth.
- Device Description: The device is an impression material, a substance used to create a mold.
- No Diagnostic Purpose: The material itself does not perform any diagnostic test on a biological sample. It is used to create a physical representation of the anatomical site.
- Input Modality: While it is scanned optically, the scanning is of the impression material, not a biological sample for diagnostic analysis.
- Anatomical Site: The anatomical site is the mouth, but the material is used to capture its physical form, not to analyze biological fluids or tissues for diagnostic purposes.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This impression material does not fit that description.
N/A
Intended Use / Indications for Use
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown & bridges, endentulous and partial impressions.
The Flexitime Fast & Scan range of products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3shape D700 laser scanners.
Product codes (comma separated list FDA assigned to the subject device)
ELW.
Device Description
Flexitime Fast & Scan Impression Materials are addition-cross-linking polyvinyl siloxane materials. The Flexitime Fast & Scan Impression Materials family consists of Light Flow, Medium Flow, Dynamix Putty, Easy Putty and Dynamix Heavy Tray. Flexitime Light Flow, Medium Flow, Heavy Tray are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty and Dynamix Heavy Tray are delivered in 380 ml Cartridges and Flexitime Fast & Scan Easy Putty is delivered in a 300 ml container.
The Flexitime Fast & Scan assortment is characterized by the addition of Titanium Dioxide (in order to ensure scannability) and is technically characterized by an extra-oral working time of up to 1.5 minutes and a short time in mouth of 2.0 minutes. The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. Also, they ensure scannability with state of the art red laser light impression scanners.
Flexitime Fast & Scan products are part of the Flexitime System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical scanning in dental scanners designed for scanning impression materials, such as the 3shape D700 laser scanners.
Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Testing:
In accordance with US FDA Medical Device Regulations, any medical device is required to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with FDA recognized standard, EN ISO 10993-1.
The biological compatibility of Flexitime Fast & Scan was verified in accordance with the international standards.
The biocompatibility of Flexitime Fast & Scan in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk relation has been judged as positive.
Clinical Testing:
In accordance with US FDA Medical Device Regulations, any medical device is required to be evaluated by the legal medical device manufacturer regarding its clinical performance and c variation by the regal nical evaluation, which is intended to critically evaluate the clinical benefits of the medical device in comparison to tis potential risks. Therefore, any clinical benefits of the medical compulsory risk management process according to FDA recognized evaluation 15 part of the son critical findings must further be considered in the current risk Standard, int process of the medical device manufacturer responsible for the evaluated device.
On this background, the clinical evaluation was performed. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.
Considering the evaluated scientific data and technical results for Flextime Fast & Scan it is concluded that the products can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and accepted, when weighed against their benefit to dentistry. Therefore, a positive benefit versus risk ratio can be stated by the experts for Flexitime Fast & Scan assortment, provided that the products are applied in accordance with the intended use as outlined in the manufacturer's instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 872.3660 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).
0
Heraeus
510(k) Summary
JUL 25 2012
510(k) summary of safety and effectiveness information for Flexitime Fast & Scan in accordance with 21 CFR 807.92.
1. Submitter Information
| Company Name: | Heraeus Kulzer, LLC |
|---|---|
| Company Address: | 300 Heraeus Way |
| South Bend, IN 46614 | |
| Company Phone: | (574) 299-5421 |
Contact Person: Jamie Mearna
Date Summary prepared: December 28, 2011(Revised June 29, 2012)
2. Device Identification
Trade /Proprietary Name:
- Flextime Fast & Scan Impression Materials to include
- Flexitime Fast & Scan Light Flow �
- ◆ Flexitime Fast & Scan Medium Flow,
- Flexitime Fast & Scan Dynamix Putty �
- . Flexitime Fast & Scan Easy Putty
- Flexitime Fast & Scan Dynamix Heavy Tray .
| Common Name: | Material, Impression (21 CFR 872.3660) |
|---|---|
| Classification: | Class II |
| FDA Code: | Dental ELW. |
3. Legally Market Devices to which Substantial Equivalence is claimed:
Heraeus Kulzer, GmBH - Flexitime Impression Material (K000629) Heraeus Kulzer, GmBH - Flexitime Fast & Scan Impression Material (K102770)
4. Device Description
Flexitime Fast & Scan Impression Materials are addition-cross-linking polyvinyl siloxane materials. The Flexitime Fast & Scan Impression Materials family consists of Light Flow, Medium Flow, Dynamix Putty, Easy Putty and Dynamix Heavy Tray. Flexitime Light Flow, Medium Flow, Heavy Tray are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty and Dynamix Heavy Tray are delivered in 380 ml Cartridges and Flexitime Fast & Scan Easy Putty is delivered in a 300 ml container.
The Flexitime Fast & Scan assortment is characterized by the addition of Titanium Dioxide (in order to ensure scannability) and is technically characterized by an extra-oral working time of up to 1.5 minutes and a short time in mouth of 2.0 minutes. The materials were developed to ensure hydrophilic characteristics for optimal impression
1
taking in the wet surroundings of the mouth combined with good mechanical properties. Also, they ensure scannability with state of the art red laser light impression scanners.
Flexitime Fast & Scan products are part of the Flexitime System.
5. Intended Use
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown & bridges, endentulous and partial impressions.
The Flexitime Fast & Scan range of products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3shape D700 laser scanners.
6. Technological Characteristics
The physical properties of the additional Flexitime Fast& Scan assortments: Dynamix Heavy Tray and Easy Putty are like Flexitime Fast and Scan (K102770) and Flexitime (K000629) products in the fact that they are also in compliance with ISO 4823.
The new assortment of Flextime Fast and Scan materials (like the original Flexitime Fast & Scan K102770) can be prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials.
7, Nonclinical Testing
In accordance with US FDA Medical Device Regulations, any medical device is required to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with FDA recognized standard, EN ISO 10993-1.
The biological compatibility of Flexitime Fast & Scan was verified in accordance with the international standards.
The biocompatibility of Flexitime Fast & Scan in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk relation has been judged as positive.
8. Clinical Testing
In accordance with US FDA Medical Device Regulations, any medical device is required to be evaluated by the legal medical device manufacturer regarding its clinical performance and c variation by the regal nical evaluation, which is intended to critically evaluate the clinical benefits of the medical device in comparison to tis potential risks. Therefore, any clinical benefits of the medical compulsory risk management process according to FDA recognized evaluation 15 part of the son critical findings must further be considered in the current risk Standard, int process of the medical device manufacturer responsible for the evaluated device.
2
On this background, the clinical evaluation was performed. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.
Considering the evaluated scientific data and technical results for Flextime Fast & Scan it is concluded that the products can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and accepted, when weighed against their benefit to dentistry. Therefore, a positive benefit versus risk ratio can be stated by the experts for Flexitime Fast & Scan assortment, provided that the products are applied in accordance with the intended use as outlined in the manufacturer's instructions for use.
9. Summary of Conclusion
The new Flexitime Fast & Scan assortment is substantially equivalent to the original Flexitime Fast & Scan and Flexitime. All of the products are indicated for taking impression materials of suited techniques. In addition, the new assortment of Flexitime Fast & Scan is scannable without prior powdering as is required with the predicate device, Flexitime Fast and Scan.
A biocompatibility evaluation has been performed by a toxicologist for Flextime Fast & Scan, and it was confirmed that the product meets the requirements of FDA recognized standard, ISO 10993 Standard and it was concluded that the safety of Flexitime Fast & Scan is equivalent to that of the predicate device.
The risk analysis was carried out for Flexitime Fast & Scan and it was concluded that the safety of the Flexitime Fast & Scan device, for the intended use, is substantially equivalent to the predicate device. Flexitime Fast & Scan and the predicate device both have the same indications for use, warnings and contraindications.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 25 2012
Mr. Jamie Mearna Quality Assurance & Regulatory Associate Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614
Re: K120914
Trade/Device Name: Flexitime Fast & Scan Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 09, 2012 Received: July 11, 2012
Dear Mr. Mearna:
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. Mearna:
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/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
For
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K/26 914
Device Name: Flexitime Fast & Scan
Indications for Use:
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, endentulous and partial impression.
The Flexitime Fast & Scan range of products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 shape D700 laser scanners.
Prescription Use V . Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 10(k) Number: | K120914 |
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