(41 days)
No
The device description and performance studies focus on the material properties and clinical performance of a resin-modified glass ionomer restorative system, with no mention of AI or ML technologies.
No
The device is a restorative material used for filling teeth, which falls under the category of dental materials, not therapeutic devices.
No
The device is described as a restorative system for dental fillings and core buildups, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a "light curing, radiopaque, fluoride-releasing, resin-modified glass ionomer restorative system" consisting of "a base and catalyst paste and a primer," available in different dispensing systems. This describes a physical material and dispensing hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to restoring and repairing teeth in vivo (within the body). IVDs are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to diagnose diseases or conditions.
- Device Description: The description details a restorative material applied directly to the tooth. This is consistent with a dental restorative device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly a dental restorative material used for direct application to the tooth structure.
N/A
Intended Use / Indications for Use
Primary teeth restorations
Small Class I restorations
Class III and Class V restorations
Transitional restorations
Filling defects and undercut areas in crown preparations
Core buildup where at least half the coronal tooth structure is remaining to provide structural support for the crown
Laminate sandwich technique
Product codes
EMA
Device Description
LCR is a light curing, radiopaque, fluoride-releasing, resin-modified glass ionomer restorative system. The restorative system consists of a base and catalyst paste and a primer. LCR is available in 8 shades. The restorative paste will be available in both the multi-dose 3M ESPE Clicker dispensing system or a unit dose option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / Dental
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)
To provide evidence for safety, the chemical composition of LCR was compared to Vitremer Core Buildup/Restorative System. Additionally, independent research institutes carried out biocompatibility testing. The results show that LCR is a safe device when used as directed. To demonstrate the effectiveness of LCR, the performance characteristics of LCR were compared to 3M ESPE Vitremer Core Buildup/Restorative System, 3M ESPE Photac-Fil Aplicap and GC Fujill LC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
SEP 2 7 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
Submitter
| Company: | 3M ESPE |
|---|---|
| Street: | 3M Center Bldg 260-2B-12 |
| City, State, Zip-code: | St. Paul, MN 55144 |
| Country: | U.S.A |
| Establishment Registration Number: | 2110898 |
| Contact: | Karen O'Malley |
| Regulatory Affairs Specialist | |
| Phone: | 651 736-7326 |
| Fax: | 651 736-0990 |
| E-mail: | kdomalley@mmm.com |
| Date of Submission: | August 9, 2005 |
Name of Device
| Proprietary Name: | LCR |
|---|---|
| Classification Name: | Dental Cement |
| Common Name: | Glass Ionomer Restorative |
Predicate Devices:
| Vitremer Core Buildup/Restorative System....... | K925032 |
|---|---|
| Photac-Fil Aplicap .................................... | K925027 |
| Fujii II LC................................................ | K993973 |
LCR is classified as a Dental Cement (21 C.F.R. § 872.3275) because it is a resin modified glass ionomer base cement used as a temporary tooth filling.
3M ESPE is submitting this Special 510(k) for modifications to Vitremer Core Buildup/Restorative System (K 925032). The modifications of Vitremer Core Buildup/Restorative System are minor changes of the chemical composition, while the basic chemical design remains the same. The change results in primarily change to the physical form of the delivered product and the means to dispense the product for placement in the dental procedure. A summary of the design change features is:
- Paste/ paste bulk and unit dose delivery system for ease of mixing and delivery as . compared to existing powder/ liquid systems.
- Consistent cement properties because of exact mixing ratio ●
- Less preparation and clean-up steps ◆
- Improved wear and polishability of the restoration .
- Improved esthetics of the restoration .
Image /page/0/Picture/16 description: The image shows the logo for 3M ESPE. Above the logo, the text "Special 510(k) LCR" is printed in a smaller font size. The 3M ESPE logo is printed in a bold, sans-serif font.
1
LCR is designed to retain the excellent physical, mechanical and clinical properties of existing Vitremer Core Buildup/Restorative System. Like Vitremer Core Buildup/Restorative System, LCR has the same basic chemical composition and material characteristics for patient application. LCR is a light curing, radiopaque, fluoride-releasing, resin-modified glass ionomer restorative system. The restorative system consists of a base and catalyst paste and a primer. LCR is available in 8 shades. The restorative paste will be available in both the multi-dose 3M ESPE Clicker dispensing system or a unit dose option.
The modified light-curing glass ionomer restorative system, LCR, has the following similarities to the currently marketed Vitremer Core Buildup/Restorative System:
- . Both restoratives have the same intended use.
- . Both are resin modified glass ionomer cements incorporating the same major chemical components.
- . Both restoratives have the same shelf life and storage conditions.
To provide evidence for safety, the chemical composition of LCR was compared to Vitremer Core Buildup/Restorative System. Additionally, independent research institutes carried out biocompatibility testing. The results show that LCR is a safe device when used as directed. To demonstrate the effectiveness of LCR, the performance characteristics of LCR were compared to 3M ESPE Vitremer Core Buildup/Restorative System, 3M ESPE Photac-Fil Aplicap and GC Fujill LC.
In summary, the modified dental restorative system, LCR, described in this Special 510(k) pre-market notification submission is substantially equivalent to the predicate devices. This is our position with regard to intended use, major chemical components, shelf life, storage conditions, safety and effectiveness.
Image /page/1/Picture/7 description: The image shows the text "Special 510(k) LCR" on the top line. Below that is the text "3M ESPE" in a larger, bold font. The text is black and the background is white. The image appears to be a logo or branding for a product or company.
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Image /page/2/Picture/1 description: The image shows a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the circumference of the circle. Inside the circle is a stylized emblem that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2005
Ms. Karen O'Malley Regulatory Affairs Specialist 3M Company 3M Center, Building 260-2B-17 St. Paul. Minnesota 55144-1000
Re: K052235
Trade/Device Name: LCR, Light-Curing Glass Ionomer Restorative System Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: September 9, 2005 Received: September 12, 2005
Dear Ms. O'Malley:
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 - Ms. O'Malley
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 and inome (s 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 vour 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" (21CFR 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 yours,
Ches
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
| 510(k) Number: | K052235 |
|---|---|
| Device Name: | LCR, Light-curing glass ionomer restorative system |
| Indications for Use: | Primary teeth restorations |
| Small Class I restorations | |
| Class III and Class V restorations | |
| Transitional restorations | |
| Filling defects and undercut areas in crown preparations | |
| Core buildup where at least half the coronal tooth | |
| structure is remaining to provide structural support for the | |
| crown | |
| Laminate sandwich technique |
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michelle for MSR
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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