(88 days)
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No
The document describes a dental impression material and its physical properties, with no mention of AI or ML.
No.
The device is an impression material used for creating dental molds, not a device that directly treats or prevents a disease or condition.
No
Explanation: This device is an impression material used to create molds of dental structures, which are then optically scanned. It is a tool for capturing anatomical information, not for interpreting or analyzing that information to make a diagnosis.
No
The device is an impression material, which is a physical substance used to create a mold. It is 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 impressions of the mouth for dental procedures (inlays, crowns, bridges, etc.). This is a physical impression of anatomical structures, not a test performed on biological samples (like blood, urine, or tissue) to provide diagnostic information about a disease or condition.
- Device Description: The device is an impression material used to capture the shape of the mouth. It's a physical material, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of Diagnostic Claims: There are no claims or indications that this device is used to diagnose, monitor, or screen for any disease or condition.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and clinical performance in creating impressions, not on diagnostic accuracy (like sensitivity, specificity, etc.).
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (in the body) to create a physical mold.
N/A
Intended Use / Indications for Use
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, edentulous and partial impression. The Flexitime Fast & Scan range 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.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
The Flexitime Fast & Scan Light Flow. Flexitime Fast & Scan Medium Flow and Flexitime Fast & Scan Dynamix Putty each are addition-cross-linking polyvinyl siloxane impression materials. Flexitime Fast & Scan Light Flow and Medium Flow are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty is delivered in 380 ml cartridges.
They are part of the Flexitime-system. The Flexitime Fast & Scan assortment is characterized by the addition of Titanium- Dioxide (in order to ensure scannabilty) and is technically characterized by a extraoral working time of up to 1.5 min and a short time in mouth of 2.0 min. These products are highly desired for double-mix impressions (single step) and correction impressions (two step technique).
The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. Furthermore the materials were developed to ensure scannability with state of the art red laser light impressions scanners. The materials are based on the existing materials D 919 (Flexitime Light Flow and Flexitime Medium Flow) and Flexitime Dynamix Putty to meet the requirements of the European and US market. Flexitime Light Flow and Flexitime Medium Flow are marketed since August 2009 and Flexitime Dynamix Putty is marketed since Mav 2007.
For the types D 942 Light Flow, D 942 Medium Flow and D 942 Dynamix Putty the following accepted laboratory prototypes have been compiled: JAG 165-02/ULL 1150-2. FRM 14240-1/FRM 14242-1 and ULL 1152-1/ULL 1152-2.
The target-performance comparisons prove that the requirements of the functional specification are fulfilled by these laboratory products. The prototypes were provided for further development and the upscaling by the process development department shows the functional specifications are fulfilled also for the scale up material.
Acc. the current shelf life report a shelf life of 24 month can be assumed.
The products fulfill all requirements of the EN ISO 4823: 2007.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
optical scanning in dental scanners designed for scanning impression materials, such as the 3 Shape D700 laser scanners.
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical- tests: 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 Evaluation: The clinical evaluation was performed in order to comply with the current European medical device legislation, in particular with MEDDEV 2.7.1. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.
Conclusion: A positive benefit versus risk ratio can be stated by the experts for Flexitime Fast & Scan, provided that the product applied in accordance with its intended use as outlined in the manufacturer's instruction for use for the clinical and the non-clinical test results.
510(k) summary: The toxicological evaluation report has confirmed that the product Flexitime Fast & Scan meets the requirements of the DIN EN ISO 10993 standard. The results were discussed in a Biocompatibility Evaluation Report and the benefit/risk-relation has been judged as positive. The physical properties of Flexitime Fast & Scan were determined in accordance with EN ISO 4823. The results have shown good properties of Flexitime Fast & Scan in accordance to this standard. Based on the results of the clinical evaluation report it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighted against their benefits in dentistry. The risk analysis (according to DIN EN ISO 14971) was carried out for Flexitime Fast & Scan and showed that the application of Flexitime Fast & Scan could be considered to be safe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the word "Heraeus" in a bold, sans-serif font. The letters are outlined in black, giving them a textured appearance. The word is centered and takes up most of the frame.
DEC 2 1 2010
Technical File
Summary of safety and effectiveness of the impression material Flexitime Fast & Scan
1. Submitter name
Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614
Contact person: Cheryl V. Zimmerman Tel. +1 (574) 299 - 5444
Date summary prepared: April, 21, 2010
2. Name of the device:
Flexitime Fast & Scan Light Flow/ Flexitime Fast & Scan Medium Flow/ Flexitime Fast & Scan Dynamix Putty The product is Regulatory Class II and the product code ELW It is used as dental impression material.
The GMDN number is 35866 and the description is Impression material, dental, silicon rubber, the UMDS number is 16-679 and the description is Dental-Abdruckmaterial, Silikongummi.
3. Substantially equivalence
Flexitime Fast & Scan (Project Name D 942) is a revised version of the products Flexitime Dynamix Putty, Flexitime Light Flow, and Flexitime Medium Flow. The main components and their ratio in Flexitime Dynamix Putty, Flexitime Medium Flow, and Light Flow and Flexitime Fast & Scan are similar. All three materials contain a substantial amount of Titanium-Dioxide, which has been used in other Heraeus Kulzer impression materials e.g. Provil Series, too. This pigment ensures together with the bright shading of the material the scanability in red light laser scanners.
1
Heraeus
page2 4. Description of the device
The products are developed under the project name D 942. The Flexitime Fast & Scan Light Flow. Flexitime Fast & Scan Medium Flow and Flexitime Fast & Scan Dynamix Putty each are addition-cross-linking polyvinyl siloxane impression materials. Flexitime Fast & Scan Light Flow and Medium Flow are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty is delivered in 380 ml cartridges.
They are part of the Flexitime-system. The Flexitime Fast & Scan assortment is characterized by the addition of Titanium- Dioxide (in order to ensure scannabilty) and is technically characterized by a extraoral working time of up to 1.5 min and a short time in mouth of 2.0 min. These products are highly desired for double-mix impressions (single step) and correction impressions (two step technique).
The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. Furthermore the materials were developed to ensure scannability with state of the art red laser light impressions scanners. The materials are based on the existing materials D 919 (Flexitime Light Flow and Flexitime Medium Flow) and Flexitime Dynamix Putty to meet the requirements of the European and US market. Flexitime Light Flow and Flexitime Medium Flow are marketed since August 2009 and Flexitime Dynamix Putty is marketed since Mav 2007.
For the types D 942 Light Flow, D 942 Medium Flow and D 942 Dynamix Putty the following accepted laboratory prototypes have been compiled: JAG 165-02/ULL 1150-2. FRM 14240-1/FRM 14242-1 and ULL 1152-1/ULL 1152-2.
The target-performance comparisons prove that the requirements of the functional specification are fulfilled by these laboratory products. The prototypes were provided for further development and the upscaling by the process development department shows the functional specifications are fulfilled also for the scale up material.
Acc. the current shelf life report a shelf life of 24 month can be assumed.
The products fulfill all requirements of the EN ISO 4823: 2007.
5. Intended use
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, edentulous and partial impression. The Flexitime Fast & Scan range 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.
2
Heraeus
page3
6: Summaries
a: Flexitime Fast & Scan (Project Name D 942) is a revised version of the products Flexitime Dynamix Putty, Flexitime Light Flow, and Flexitime Medium Flow. The main components and their ratio in Flexitime Dynamix Putty, Flexitime Medium Flow, and Light Flow and Flexitime Fast & Scan are similar. All three materials contain a substantial amount of Titanium-Dioxide, which has been used in other Heraeus Kulzer impression materials e.g. Provil Series, too. This pigment ensures together with the bright shading of the material the scanability in red light laser scanners.
b: Nonclinical and Clinical Tests/Evaluations
(1) Nonclinical- tests: In accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with 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/riskrelation has been judged as positive.
(2) Clinical Evaluation
In accordance with the medical Device directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes a clinical evaluation in accordance with MEDDEV 2.7.1., which is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, any clinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device.
On this background, the clinical evaluation was performed in order to comply with the current European medical device legislation, in particular with MEDDEV 2.7.1. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.
Flexitime Fast & Scan is an impression material system, which is generally classified as a class I medical device under the Medical Device Directive 93/42/EEC.
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Heraeus
page4
Considering the evaluated scientific data and technical results for Flexitime 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 acceptable, when weighed against their benefits in dentistry. Therefore, a positive benefit versus risk ratio can be stated by the experts for Flexitime Fast & Scan, provided that the products applied in accordance with its intended use as outlined in the manufacturer's instruction for use.
The clinical evaluation report was prepared in accordance with MEDDEV 2.7.1 and followed the provisions of the corresponding clinical evaluation plan.
(3) Conclusion
A positive benefit versus risk ratio can be stated by the experts for Flexitime Fast & Scan, provided that the product applied in accordance with its intended use as outlined in the manufacturer's instruction for use for the clinical and the non-clinical test results.
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page5
(c) 510 (k) summary
The risk potential of the Flexitime Fast & Scan was proved considering the current composition. All properties of the product were verified successfully.
The biological compatibility of the impression material was investigated to evaluate the toxicological risk. A toxicological evaluation report has confirmed that the product Flexitime Fast & Scan meets the requirements of the DIN EN ISO 10993 standard. The results were discussed in a Biocompatibility Evaluation Report and the benefit/risk-relation has been judged as positive.
The physical properties of Flexitime Fast & Scan were determined in accordance with EN ISO 4823. The results have shown good properties of Flexitime Fast & Scan in accordance to this standard.
Based on the results of the clinical evaluation report it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighted against their benefits in dentistry.
The risk analysis (according to DIN EN ISO 14971) was carried out for Flexitime Fast & Scan and showed that the application of Flexitime Fast & Scan could be considered to be safe.
Flexitime Fast & Scan meets all requirements relevant for dental impression material in accordance with the Medical Device directive 93/42/EWG and national European medical device legislation. Based on the actual facts Flexitime Fast & Scan could be evaluated to be effective and safe with its intended use as outlined in the manufacturer's instruction for use.
Dormagen, September 15, 2010
Andreas
i.V. Gausse
Dr. A. Grundler
i.A. H.Hausu
Heike Jansen
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The text is likely part of a document or sign.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 1 2010
Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 300 Heraeus Way South Bend, Indiana 46614
Re: K102770
Trade/Device Name: Flexitime Fast & Scan (Light Flow, Medium Flow, and Dynamix Putty) .
Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: September 22, 2010 Received: September 24, 2010
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. 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 – Ms. Zimmerman
Enclosure
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 yours,
Nh 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
DEC 2 1 2010
510(k) Number (if known): K102770
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, edentulous and partial impression.
The Flexitime Fast & Scan range 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 | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (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 Page 1of1
Infection Control, Dental Devices
510(k) Number: K02770