(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a silicone impression material, with no mention of AI or ML.
No
The device is an impression material used to take dental impressions for crowns, bridges, implants, and orthodontics, which are diagnostic or procedural materials, not therapeutic.
No
This device is an impression material used for creating physical molds of oral structures, not for diagnosing conditions.
No
The device description clearly states it is an "addition type silicone 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 for taking dental impressions of various types (crown, bridge, inlay, onlay, implants, orthodontic). This is a physical process used to create a mold of anatomical structures.
- Device Description: The device is an addition type silicone impression material. This is a material used to capture the shape of the teeth and surrounding tissues.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose. The material is used to create a physical impression, not to analyze a biological sample or provide information about a patient's health status.
- No Mention of Biological Samples: IVD devices are typically used to test biological samples (blood, urine, tissue, etc.). This device is used directly in the mouth to capture a physical form.
Therefore, this device falls under the category of a dental impression material, which is not considered an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
All types of impressions, e.g .:
• Crown, bridge, inlay, and onlay preparations
• Implants
• Orthodontic impressions
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Flash Penta™ MB Quick and Flash MB Quick are addition type silicone impression materials of medium consistency. Flash Penta MB Quick is mixed in the Pentamix mixing device, while Flash MB Quick can be applied directly using the Garant™ dispenser. Both products are used in mono-phase technique and in one-step technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
This 510(k) submission includes data from bench testing to evaluate the performance of Flash Penta MB Quick and Flash MB Quick compared to predicate devices Flash Penta HB Q, Flash Heavy Body Q, Flash Regular Body Q and Flash Light Body. The properties evaluated include consistency, total working time, detail reproduction, linear dimensional v change, compatibility with gypsum type 3 / type 4, recovery from deformation and strain in compression.
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.
Flash Penta™ HB Q (K120438), Flash Heavy Body Q (K120438), Flash Regular Body Q (K120438), Flash Light Body (K120438)
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
CM
Carl-Schurz-Straße 1 41453 Neuss Germany
Postal Address: ESPE Platz 82229 Seefeld Germany 金 +49 (0)8152 700-0 岛 +49 (0)8152 700-1366 Internet: www.3MESPE.de E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179
510(k) Summary
| 510(k) submitter: | 3M Deutschland GmbH
ESPE Platz
82229 Seefeld
Germany
Establishment Registration Number: 9611385 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruediger Franke
Regulatory Affairs Specialist
Phone: +49-8152-700 1802
Fax: +49-8152-700 1869
e-mail: ruediger.franke@3M.com |
| Date: | March 05, 2014 |
| Trade Name: | Flash Penta™ MB Quick
Flash MB Quick |
| Common Name: | VPS impression material |
| Classification Name: | Impression material
(21 CFR 872.3660, product code ELW) |
| Predicate Devices | Flash Penta™ HB Q (K120438)
Flash Heavy Body Q (K120438)
Flash Regular Body Q (K120438)
Flash Light Body (K120438) |
Description of Device
Flash Penta™ MB Quick and Flash MB Quick are addition type silicone impression materials of medium consistency. Flash Penta MB Quick is mixed in the Pentamix mixing device, while Flash MB Quick can be applied directly using the Garant™ dispenser. Both products are used in mono-phase technique and in one-step technique.
Image /page/0/Picture/11 description: The image contains a logo and some text. The logo is a circular design with a dot above it. The text reads "Deutsche Dental" and "Page 5 of 198". The text is located to the right of the logo.
1
Indications for Use:
All types of impressions, e.g .:
· Crown, bridge, inlay, and onlay preparations
· Implants
· Orthodontic impressions
Substantial Equivalence
Information provided in this 510(k) submission shows that Flash Penta MB Quick and Flash MB Quick are substantially equivalent to the predicate devices Flash Penta HB Q, Flash Heavy Body Q. Flash Regular Body Q and Flash Light Body in terms of intended use, indications for use, composition and physical properties. A biocompatibility assessment was developed for Flash Penta MB Quick and Flash MB Quick using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that Flash Penta MB Quick and Flash MB Quick are safe for their intended use.
This 510(k) submission includes data from bench testing to evaluate the performance of Flash Penta MB Quick and Flash MB Quick compared to predicate devices Flash Penta HB Q, Flash Heavy Body Q, Flash Regular Body Q and Flash Light Body. The properties evaluated include consistency, total working time, detail reproduction, linear dimensional v change, compatibility with gypsum type 3 / type 4, recovery from deformation and strain in compression.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another, represented by abstract shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
June 5, 2014
3M Deutschland GmbH Ruediger Franke Regulatory Affairs Specialist ESPE Platz Seefeld, Bavaria Germany 82229
Re: K140602
Trade/Device Name: Flash Penta™ MB Quick, Flash MB Quick Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 5, 2014 Received: March 10, 2014
Dear Mr. Franke:
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.
3
Page 2 - Mr. Franke
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/Resourcesfor You/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,
Mary's Runner -S
Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name Flash Penta MB Quick and Flash MB Quick
Indications for Use (Describe)
All types of impressions, e.g .:
· Crown, bridge, inlay, and onlay preparations
• Implants
· Orthodontic impressions
Type of Use (Select one or both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
****************************************************************************************************************************************************************************** Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Sheena 2014.06.05
FORM FDA 3881 (1/14)
Page 1 of 2
Ef になる。 そのためには、 Security on 1 4113 43 347 17 12 15 1
510(k) Submission: Flash Penta MB Quick & Flash MB Quick
3M Confidential