(4 days)
K 933139, K 001730
K 933139, K 001730
No
The device description and intended use are for a dental cement, and there is no mention of AI or ML in the provided text.
No.
The device is a luting cement used for bonding dental restorations and appliances; it does not treat or prevent a disease or condition.
No
This device is a luting cement used for bonding dental restorations and orthodontic appliances. Its function is to physically connect materials, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement" and is packaged in a "3M ESPE Clicker dispensing system," indicating it is a physical material and dispensing hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that this device is a luting cement used to bond dental restorations (crowns, bridges, inlays, etc.) to tooth structure. This is a direct application within the body (in vivo), not a test performed on a sample outside the body (in vitro).
- Intended Use: The intended use is for cementing dental appliances, not for diagnosing any medical condition.
- Device Description: The description details the chemical composition and dispensing system of a cement, not a diagnostic test kit or instrument.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, this device is a dental material used for bonding and is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
Luting metal inlays, onlays or crowns;
Luting pre-fabricated and cast post cementation
Luting orthodontic appliances
Luting crowns made with all-alumina or allzirconia cores such as Procera® AllCeram
Product codes
EMA
Device Description
RelyX RMGIP is classified as a Dental Cement (21 C.F.R. § 872.3275) because it is a base cement used to affix dental devices such as crowns or bridges.
RelyX RMGIP cement is a self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. The cement consists of a base and catalyst paste packaged in the 3M ESPE Clicker dispensing system. RelyX RMGIP is available in a white shade.
The modifications of RelyX Luting Cement concern minor changes of the chemical composition, however, the basic chemical design remains the same. The change is primarily 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 is:
- Paste/ paste 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure
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 RelyX RMGIP was compared to RelyX Luting Cement. Additionally, independent research institutes carried out biocompatibility testing. The results show that RelyX RMGIP is a safe device when used as directed.
To demonstrate the effectiveness of RelyX RMGIP, the performance characteristics of RelyX RMGIP were compared to RelyX Luting Cement and GC FujiCEM.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 933139, K 001730
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
AUG 0 2 2002
KCD2476
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: | July 24, 2002 |
| Name of Device | |
| Proprietary Name: | RelyX RMGIP |
| Classification Name: | Dental Cement |
| Common Name: | Luting Cement |
| Predicate Device: | |
| RelyX Luting Cement | K 933139 |
| GC FujiCEM | K 001730 |
| Description for the Premarket Notification |
RelyX RMGIP is classified as a Dental Cement (21 C.F.R. § 872.3275) because it is a base cement used to affix dental devices such as crowns or bridges.
Image /page/0/Picture/6 description: The image shows the text "Special 510(k) RelyX TM RMGIP" on the top line. Below that is the text "3M ESPE" in a larger font. The text is black and the background is white. The image appears to be a logo or product name.
1
3M ESPE is submitting this Special 510(k) for modifications to RelyX Luting Cement. The modifications of RelyX Luting Cement concern minor changes of the chemical composition, however, the basic chemical design remains the same. The change is primarily 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 is:
- Paste/ paste 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 .
RelyX RMGIP is designed to retain the excellent physical, mechanical and clinical properties of existing RelyX Luting Cement. Like RelyX Luting Cement and GC FujiCEM, RelyX RMGIP has the same basic chemical composition and material characteristics for patient application. RelyX RMGIP cement is a self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. The cement consists of a base and catalyst paste packaged in the 3M ESPE Clicker dispensing system. RelyX RMGIP is available in a white shade.
The modified luting cement, RelyX RMGIP, has the following similarities to the currently marketed RelyX Luting Cement:
- . Both cements have the same intended use.
- Both are resin modified glass ionomer cements incorporating the same major . chemical components.
- Both cements have the same shelf life and storage conditions.
To provide evidence for safety, the chemical composition of RelyX RMGIP was compared to RelyX Luting Cement. Additionally, independent research institutes carried out biocompatibility testing. The results show that RelyX RMGIP is a safe device when used as directed.
To demonstrate the effectiveness of RelyX RMGIP, the performance characteristics of RelyX RMGIP were compared to RelyX Luting Cement and GC FujiCEM.
In summary, the modified dental cement, RelyX RMGIP, described in this Special 510(k) pre-market notification submission is substantially equivalent to the predicate device. This is our position with regard to intended use, major chemical components, shelf life, storage conditions, safety and effectiveness,.
Image /page/1/Picture/12 description: The image shows the text "Special 510(k) RelyX TM RMGIP" on the top line. Below that is the text "3M ESPE" in a larger, bold font. The text is black on a white background. The image appears to be a logo or product name.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 02 2002
Ms. Karen O'Malley Regulatory Affairs Specialist 3M ESPE 3M Center Building 260-2B-12 Saint Paul, Minnesota 55144
Re: K022476
Trade/Device Name: RelyX RMGIP Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 24, 2002 Received: July 29, 2002
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.
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.
3
Page 2 - Ms. O'Malley
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Patricia Caccavale/for
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
Device Name:
RelyX RMGIP
Indications for use:
Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
Luting metal inlays, onlays or crowns;
Luting pre-fabricated and cast post cementation
Luting orthodontic appliances
Luting crowns made with all-alumina or allzirconia cores such as Procera® AllCeram
Susan Runn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Reyiers 510(k) Number .
Prescription use: 7
Over the counter use: