(16 days)
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No
The document describes dental impression materials and their dispensing devices, with no mention of AI or ML capabilities.
No
The device is described as an "impression material" intended to reproduce the structure of a patient's teeth, which is a diagnostic rather than therapeutic function.
No
The document describes impression materials used to reproduce the structure of a patient's teeth for dual phase impression techniques. These materials are used for creating models of teeth, which is not a diagnostic function. Diagnostics involves identifying or determining the nature of a disease or condition.
No
The device description clearly states that Future Wash and YPS are "wash material" and "tray material" respectively, which are physical substances used for dental impressions. It also mentions they are two-component materials dispensed by physical mixing devices (Garant™ and Pentamix™ 2). This indicates a physical, material-based device, 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 "reproduce the structure of a patient's teeth" for dental impressions. This is a physical process for creating a mold, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is classified as "Impression materials" and is used to create a physical reproduction of teeth.
- Lack of Diagnostic Purpose: There is no mention of analyzing a sample (blood, urine, tissue, etc.) or providing information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on biocompatibility and comparison to predicate devices for effectiveness in creating impressions, not on diagnostic accuracy or clinical outcomes related to a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step): Wash material for all kinds of dual phase impression techniques.
YPS (YPS Penta™ HB Quick Step): Tray material for all kinds of dual phase impression techniques.
Product codes
ELW
Device Description
Future Wash and YPS 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.
Future Wash will be available as wash material in two different viscosities (light body, regular body), each of them in a regular-sct and a quick-set version, and YPS will be a tray material in a quick-set version.
3M ESPE is submitting this special 510(k) for modifications to its silicone impression materials Dimension™ Garant™ L and Dimension™ Penta™ H.
The Future Wash materials are two component (base paste/catalyst) materials designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™. YPS is a two component (base paste/catalyst) materials to automatically be mixed and dispensed in the 3M ESPE's Pentamix™ 2 device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
To prove the effectiveness of Future Wash and YPS, their performance characteristics were compared to those of the respective predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To provide evidence for safety biocompatibility testing was carried out. The results show that Future Wash and YPS are safe devices.
To prove the effectiveness of Future Wash and YPS, their performance characteristics were compared to those of the respective predicate devices.
In summary, Future Wash and YPS, described in this 510(k) premarket notification submission, are, in our opinion, substantially equivalent to the respective predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dimension™ Garant™ L, K000588, Dimension™ Penta™ H, K000591
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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:
1205 1797
JUL 2 1 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter | |
|---|---|
| Company: | 3M ESPE AG |
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, |
| Manager Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | andreas.petermann@mmm.com |
| Date: | July 1, 2005 |
1
Name of Device
| Proprietary Name: | Future Wash Light Body |
|---|---|
| Future Wash Light Body Quick Step | |
| Future Wash Regular Body | |
| Future Wash Regular Body Quick Step | |
| YPS Penta™ HB Quick Step |
Impression material
Common Name: Dental impression material
Predicate Devices:
Classification Name
Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step:
Dimension™ Garant™ L, K000588
YPS Penta HB Quick Step:
Dimension™ Penta™ H, K000591
Description for the Premarket Notification
Future Wash and YPS 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.
Future Wash will be available as wash material in two different viscosities (light body, regular body), each of them in a regular-sct and a quick-set version, and YPS will be a tray material in a quick-set version.
3M ESPE is submitting this special 510(k) for modifications to its silicone impression materials Dimension™ Garant™ L and Dimension™ Penta™ H.
The Future Wash materials are two component (base paste/catalyst) materials designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™. YPS is a two
2
component (base paste/catalyst) materials to automatically be mixed and dispensed in the 3M ESPE's Pentamix™ 2 device.
To provide evidence for safety biocompatibility testing was carried out. The results show that Future Wash and YPS are safe devices.
To prove the effectiveness of Future Wash and YPS, their performance characteristics were compared to those of the respective predicate devices.
In summary, Future Wash and YPS, described in this 510(k) premarket notification submission, are, in our opinion, substantially equivalent to the respective predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which is a stylized representation of three human profiles facing right, arranged in a vertical stack. The profiles are connected by a flowing line that suggests movement or progress. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2005
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY
Re: K051797
Trade/Device Name: Future Wash and YPS PentaTM Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 01, 2005 Received: July 05, 2005
Dear Dr. Petermann:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Andreas Petermann
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, 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): L051797
Device Name: Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step)
YPS (YPS Penta™ HB Quick Step)
Indications For Use:
Future Wash (Future Wash Light Body, Future Wash Light Body Quick Step, Future Wash Regular Body, Future Wash Regular Body Quick Step): Wash material for all kinds of dual phase impression techniques.
YPS (YPS Penta™ HB Quick Step): Tray material for all kinds of dual phase impression techniques.
Prescription Use (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)
Robert Seter DDS for Dr. Susan Runner
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510(k) Number