(119 days)
- Impressions for the production of temporary restorations .
- . All types of preliminary impressions
- . Impressions of the opposing jaw
- Impressions for orthodontic models .
Flash AR and Flash AR Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth. As the predicate devices Flash AR Penta™ and Flash AR Penta™ Quick (K131404), Flash AR and Flash AR Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Flash AR Penta™ and Flash AR Penta™ Quick, Flash AR and Flash AR Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials to be used for impressions, where typically alginates are used. Whereas Flash AR Penta™ and Flash AR Penta™ Quick are designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH and the mixing ratio for both materials is base paste:catalyst, 5:1 (by volume), Flash AR and Flash AR Ouick will be delivered in Garant™ cartridges (50 ml plastic cartridges) and can be mixed and extruded using the Garant™ dispenser manufactured by 3M Deutschland GmbH with the mixing ratio for both materials of base paste:catalyst, 1:1 (by volume).
The provided text describes a 510(k) premarket notification for two dental impression materials, Flash AR and Flash AR Quick. The study presented focuses on demonstrating substantial equivalence to predicate devices rather than the performance of an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, MRMC study, standalone study, and training set details) are not applicable to this submission.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Property as per ISO 4823) | Flash AR Performance | Flash AR Quick Performance |
|---|---|---|
| Working Time | Same as predicate device Flash AR Penta | Same as predicate device Flash AR Penta Quick |
| Intra-oral Setting Time | Same as predicate device Flash AR Penta | Same as predicate device Flash AR Penta Quick |
| Material Consistency (ISO Type 2) | Medium-bodied A-silicone impression material | Medium-bodied A-silicone impression material |
| Biocompatibility | Biocompatible for intended use | Biocompatible for intended use |
| Indications for Use | Same as predicate device Flash AR Penta | Same as predicate device Flash AR Penta Quick |
| Mixing Ratio (Base:Catalyst) | 1:1 (by volume, in Garant™ cartridges) | 1:1 (by volume, in Garant™ cartridges) |
| Chemical Composition | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
| Physical and Mechanical Properties | Substantially equivalent to predicate devices | Substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The study references "Test results according to ISO 4823" and "Biocompatibility testing," but does not detail the sample sizes for these tests.
- Data Provenance: The tests were conducted to establish substantial equivalence to predicate devices manufactured by 3M Deutschland GmbH, Germany. The actual location of the testing is not explicitly stated, but given the company's location, it is likely that the studies were performed in Germany or under the purview of a German entity. The exact nature (retrospective or prospective) of the physical/mechanical and biocompatibility testing is not specified, but typically these types of studies for product equivalency are laboratory-based and controlled.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable as the submission is for a dental impression material, not an AI/ML powered device requiring interpretation by experts to establish ground truth. Substantial equivalence was based on physical, mechanical, chemical, and biocompatibility testing against ISO standards and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as the submission is for a dental impression material. Ground truth in this context is established through objective physical, mechanical, chemical, and biological tests, not through expert consensus requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable as the submission is for a dental impression material and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the submission is for a dental impression material and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance was established through:
- Objective physical and mechanical property measurements: Conducted according to ISO 4823, comparing working time, intra-oral setting time, consistency, and other properties.
- Chemical composition analysis: To ensure similarity with predicate devices.
- Biocompatibility evaluations: Performed in consideration of FDA and internationally recognized guidelines.
- The primary "ground truth" for the submission's goal was the established performance and safety of the predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick), against which substantial equivalence was demonstrated.
8. The sample size for the training set
- This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set."
9. How the ground truth for the training set was established
- This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set" or ground truth for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence evaluation comparing the new devices (Flash AR and Flash AR Quick) to their predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick). This evaluation involved:
- Performance testing: According to ISO 4823, focusing on physical and mechanical properties such as working time and intra-oral setting time. The new devices reportedly had the "same" working and intra-oral setting times as their respective predicates.
- Chemical composition comparison: Demonstrating similarity to the predicate devices.
- Biocompatibility evaluations: Performed under FDA and international guidelines, concluding that the materials are biocompatible for their intended use.
- Indications for Use comparison: Establishing that the new devices share the same intended uses as the predicate devices.
The conclusion of the study was that Flash AR and Flash AR Quick are substantially equivalent in safety and effectiveness to the predicate devices, thereby meeting the necessary criteria for regulatory clearance.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR - 7 2014
Submitter
| Company: | 3M Deutschland GmbH |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Desi W. Soegiarto,Regulatory Affairs Specialist |
| Phone: | +49-8152-700 1169 |
| Fax: | +49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | November 05, 2013(revised on December 02, 2013) |
Name of Devices
| Proprietary Name: | Flash AR |
|---|---|
| Flash AR Quick | |
| Classification Name: | Impression material |
| Common Name: | Dental impression material |
Predicate Devices
Flash AR Penta™, Flash AR Penta™ Quick by 3M Deutschland GmbH, Germany ..............................................................................................................................................
.
Amendment 510(k) Submission
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Description for the Premarket Notification
Flash AR and Flash AR Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth.
As the predicate devices Flash AR Penta™ and Flash AR Penta™ Quick (K131404), Flash AR and Flash AR Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Flash AR Penta™ and Flash AR Penta™ Quick, Flash AR and Flash AR Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials to be used for impressions, where typically alginates are used.
Whereas Flash AR Penta™ and Flash AR Penta™ Quick are designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH and the mixing ratio for both materials is base paste:catalyst, 5:1 (by volume), Flash AR and Flash AR Ouick will be delivered in Garant™ cartridges (50 ml plastic cartridges) and can be mixed and extruded using the Garant™ dispenser manufactured by 3M Deutschland GmbH with the mixing ratio for both materials of base paste:catalyst, 1:1 (by volume).
In this 510(k) premarket notification Flash AR and Flash AR Quick have been compared to the predicate devices with regard to indications for use, physical and mechanical properties, and chemical composition.
Test results according to ISO 4823 showed that Flash AR and Flash AR Quick are substantially equivalent to the predicate devices Flash AR Penta and Flash AR Penta Quick. Flash AR has same working time and intra-oral setting time as its predicate device Flash AR Penta, whereas working time and intra-oral setting time of Flash AR Quick are the same as those of its predicate device Flash AR Penta Quick. The indications for use of Flash AR and Flash AR Quick are the same as those of the predicate devices Flash AR Penta and Flash AR Penta Quick. Comparison for indications for use, performance data, and chemistry shows that Flash AR and Flash AR Quick are substantially equivalent to the predicate devices.
{2}------------------------------------------------
Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Flash AR and Flash AR Quick in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash AR and Flash AR Quick materials are biocompatible for its intended use.
In summary, it can be concluded that Flash AR and Flash AR Quick are substantially equivalent in safety and effectiveness as the predicate devices Flash AR Penta™ and Flash AR PentaTM Quick by 3M Deutschland GmbH, Germany (K131404).
Indications for Use:
- Impressions for the production of temporary restorations .
- . All types of preliminary impressions
- . Impressions of the opposing jaw
- Impressions for orthodontic models .
{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 consists of a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002
March 7, 2014
3M Deutschland GmbH Dental Products Desi Soegiarto, PhD Regulatory Affairs Specialist ESPE Platz D-82229 Seefeld GERMANY
Re: K133436
Trade/Device Name: Flash AR and Flash AR Quick Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 3, 2013 Received: December 6, 2013
Dear Dr. Soegiarto:
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 ffor 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 - Dr. Soegiarto
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image contains the text "Erin FReith -S". The text is written in a bold, sans-serif font. The word "FReith" is stylized with a decorative border around the letters. The letters are all capitalized, and the text is left-aligned.
Erin I. Keith, M.S. Acting Division 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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Indications for Use
510(k) Number (if known):
Device Name:
Flash AR Flash AR Quick
Indications for Use:
- Impressions for the production of temporary restorations .
- All types of preliminary impressions .
- Impressions of the opposing jaw .
- Impressions for orthodontic models .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner-S
FDA
03/13/07
08/28/05'00
Page 1 of 1
510(k) Submission: Flash AR & Flash AR Quick; Nov. 05, 2013
Page 11 of 240
§ 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).