(9 days)
3M™ ESPETM HAUR
Not Found
No
The summary describes a dental restorative material and its physical properties, with no mention of AI or ML.
No.
The device is a dental restorative composite material used for fillings and other dental repairs, not for treating diseases or conditions.
No
The device is a restorative material used for direct and indirect restorations, core build-ups, and splinting, which are treatment procedures, not diagnostic ones. The performance studies also focus on material properties rather than diagnostic accuracy.
No
The device description explicitly states it is a "restorative composite," which is a physical material, not software. The performance studies also focus on material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct and indirect restorations, core build-ups, and splinting of teeth. These are procedures performed directly on the patient's tooth structure.
- Device Description: It's described as a "restorative composite," which is a material used to fill cavities and restore tooth shape and function.
- Anatomical Site: The anatomical site is the "Tooth."
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are typically used in a laboratory setting or point-of-care setting to perform tests on biological specimens.
The device is a dental restorative material used for direct clinical application, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- Splinting
- Indirect restorations including inlays, onlays and veneers.
Product codes
EBF
Device Description
Filtek™ Supreme Ultra Universal Restorative is a visible-light activated, radiopaque, restorative composite.
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 Filtek™ Supreme Ultra Universal Restorative compared to predicate device 3MTM ESPETM HAUR. The properties evaluated include Compressive strength, Diametral Tensile Strength, Flexural strength, Flexural Modulus, Surface hardness, Radio-opacity, Water Sorption, Water Solubility, Polish Retention and Fluorescence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3M™ ESPE™ HAUR
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
3M ESPE
510(k) Summary 5.
3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
DEC 1 7 2008
3M ESPE
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter................................ | 3M Company
3M ESPE Dental Products
3M Center, Bldg. 275-2W-08
St. Paul, MN 55144-1000 USA
Establishment Registration Number
2110898 |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person................................ | Scott Erickson
Regulatory Affairs Specialist
Phone: (651) 736-9883
Fax: (651) 736-1599
sterickson@mmm.com |
| Date Summary was Prepared......... | 12/05/2008 |
| Trade Name................................ | FiltekTM Supreme Ultra Universal
Restorative |
| Common Name(s)......................... | Tooth shade resin material |
| Recommended Classification........ | Tooth shade resin material
(21 CFR 872.3690,
Product Code: EBF) |
Predicate Devices: 3M™ ESPE™ HAUR
Description of Device: Filtek™ Supreme Ultra Universal Restorative is a visible-light activated, radiopaque, restorative composite.
Filtek™ Supreme Ultra Universal Restorative 510(k)
:
1
3M ESPE
Indications for Use:
- · Direct anterior and posterior restorations (including occlusal surfaces)
- · Core Build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
Substantial Equivalence:
Information provided in this 510(k) submission shows that Filtek TM Supreme Ultra Universal Restorative is substantially equivalent to the predicate device 3M™ ESPETM HAUR in terms of intended use, indications for use, composition, physical properties and technological characteristics. A biocompatibility assessment was developed for FiltekTM Supreme Ultra Universal Restorative using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that Filtek™ Supreme Ultra Universal Restorative is safe for its intended use.
This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Supreme Ultra Universal Restorative compared to predicate device 3MTM ESPETM HAUR. The properties evaluated include Compressive strength, Diametral Tensile Strength, Flexural strength, Flexural Modulus, Surface hardness, Radio-opacity, Water Sorption, Water Solubility, Polish Retention and Fluorescence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Erickson Regulatory Affairs Specialist 3M Company 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul, Minnesota 55144-1000
DEC 1 7 2008
Re: K083610
Trade/Device Name: Filtek™ Supreme Ultra Universal Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 5, 2008 Received: December 8, 2008
Dear Mr. Erickson:
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.
3
Page 2 - Mr. Erickson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snjite H. Michie Dmd
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3M ESPE
Indications for Use Statement 4.
Indications for Use
1.683610 510(k) Number (if known):
Device Name: Filtek™ Supreme Ultra Universal Restorative
Indications for Use:
- · Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- · Splinting
- · Indirect restorations including inlays, onlays and veneers
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 1000 Kunte
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page _ of _
510(k) Number: K053610
Filtek™ Supreme Ultra Universal Restorative 510(k)
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