(15 days)
Not Found
No
The device description and summary of performance studies focus on the material properties and substantial equivalence to predicate impression materials, with no mention of AI or ML.
No
The device is an impression material used to reproduce the structure of a patient's teeth for various dental procedures, not to treat or cure a disease or condition.
No
The device is an impression material designed to reproduce the structure of a patient's teeth for various types of impressions, not to diagnose a medical condition.
No
The device description clearly states that the device is an "A-silicone impression material" which is a physical substance, not software. It is a two-component vinyl polysiloxane material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that Flash AR Penta™ and Flash AR Penta™ Quick are impression materials used to reproduce the structure of a patient's teeth. This process involves taking an impression directly from the patient's mouth, not analyzing a sample taken from the body in a laboratory setting.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. The focus is solely on creating a physical mold of the teeth.
Therefore, based on the provided text, this device falls under the category of a dental impression material used for creating physical models, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
- Impressions for the production of temporary restorations
- All types of preliminary impressions .
- Impressions of the opposing jaw .
- Impressions for orthodontic models .
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Flash AR Penta™ and Flash AR Penta™ 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.
Flash AR Penta™ and Flash AR Penta™ Quick have been developed based on Position Penta™ and Position Penta™ Quick of 3M Deutschland GmbH (K974231), predicate devices to which Flash AR Penta™ and Flash AR Penta™ Quick have been compared. As the predicate devices Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 5:1 (by volume).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth (implied)
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)
Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Flash AR Penta™ and Flash AR Penta™ Quick in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash AR Penta™ and Flash AR Penta™ Quick materials are biocompatible for its intended 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
(
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 3 0 2013
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: | March 06, 2013 |
Name of Devices
| Proprietary Name: | Flash AR Penta™ |
|---|---|
| Classification Name: | Impression material |
| Common Name: | Dental impression material |
Predicate Devices
:
| Position Penta TM & Position Penta TM Quick | |
|---|---|
| by 3M Deutschland GmbH, Germany | K974231 |
| Flash | |
| by 3M Deutschland GmbH, Germany | K120438 |
1
Description for the Premarket Notification
Flash AR Penta™ and Flash AR Penta™ 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.
Flash AR Penta™ and Flash AR Penta™ Quick have been developed based on Position Penta™ and Position Penta™ Quick of 3M Deutschland GmbH (K974231), predicate devices to which Flash AR Penta™ and Flash AR Penta™ Quick have been compared. As the predicate devices Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 5:1 (by volume).
In this 510(k) premarket notification Flash AR Penta™ and Flash AR Penta™ Quick have been compared to the predicate devices with regard to indications for use, physical and mechanical properties, and chemical composition. The comparison for indications for use, performance data, and chemistry shows that Flash AR Penta™ and Flash AR Penta™ Quick are substantially equivalent to the predicate devices.
Biocompatibility testing was carried out. Biocompatibility evaluations have been performed for Flash AR Penta™ and Flash AR Penta™ Quick in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that Flash AR Penta™ and Flash AR Penta™ Quick materials are biocompatible for its intended use.
In summary, it can be concluded that Flash AR Penta™ and Flash AR Penta™ Quick are as substantially equivalent in safety and effectiveness as the predicate devices Position Penta™ & Position Penta™ Quick by 3M Deutschland GmbH, Germany (K974231) and Flash materials by 3M Deutschland GmbH, Germany (K120438).
2
.
Indications for Use:
- · Impressions for the production of temporary restorations
- All types of preliminary impressions .
- Impressions of the opposing jaw .
- Impressions for orthodontic models .
5 10(k) Submission: Flash AR Penta & Flash AR Penta Quick; March 06, 2013
,
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 caduceus symbol, which features three intertwined strands and a base resembling a wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2013
3M Deutschland GmbH C/O Mr. Alexander Schapovalov TUV SUD America, Incorporated 1775 Old Highway 8 North West NEW BRIGHTON MN 55112-1891
Re: K131404
Trade/Device Name: Flash AR Penta™, Flash AR Penta™ Quick Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 13, 2013 Received: May 23, 2013
Dear Mr. Schapovalov:
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.
4
Page 2 - Mr. Schapovalov
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 devicerelated 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
| | Digitally signed by Mary S. Runner -S
ON: C=US, O=U.S. Government,
OU=HHS, OU=FDA, ou=People,
cn=Mary S. Runner -5,
0.9.2342.19200300.100.1.1=13000879 |
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Susan Runner, DDSMA |
| | Date: 2013.05.30 10:37:12 -04'00' |
Anthony D. Watson, B.S., M.S., M.B.A.
Director
Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
1.5 Statement of Indications for Use
Indications for Use
| 510(k) Number (if known): | K131404 |
|---|---|
| --------------------------- | --------- |
Device Name:
Flash AR Penta™ Flash AR Penta™ 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 (Part 21 CFR 301 Subpart D) | X |
|---|---|
| ---------------------------------------------- | ---------- |
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)
Digitally signed by Mary S. Runner -S
DN: c=US; o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner
0.9.2342.19200300.100.1.1=1300087950
Date: 2013.05.30 10:35:04 -04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | KB1404 |
|---|---|
| ---------------- | -------- |
| Page 1 of | 1 |
|---|---|
| ----------- | --- |