(45 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a glass ionomer dental cement, with no mention of AI or ML.
No
The device is classified as a dental cement intended for protective coating and lining, not for treating a disease or condition in a therapeutic manner beyond protection and sensitivity relief.
No
The device, GILB-2, is described as a protective coating and dental cement used for lining, basing, and treating exposed root surface sensitivity and non-cavitated lesions. Its intended uses are therapeutic and protective, not for diagnosing conditions.
No
The device description clearly states it is a "two part liquid/paste system" and is contained in a "Clicker™ Dispensing System," indicating it is 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 direct application to tooth surfaces for protection, lining, basing, and treating sensitivity. These are therapeutic and protective functions performed in vivo (on the living patient), not diagnostic tests performed in vitro (outside the body).
- Device Description: The description clearly states it's a "Dental Cement" and describes its application as a "cavity liner/basing material" and "protective coating." This aligns with a material used for treatment and protection within the mouth.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing information for diagnosis. The device's function is purely physical and chemical interaction with the tooth structure.
- Classification: It is classified as "Dental Cement (21 C.F.R§872.3275)," which is a classification for devices used in dental procedures, not for in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
-
- Lining and basing applications under composite, amalgam, ceramic or metal restorations.
-
- Treatment of exposed root surface sensitivity
-
- Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions
Product codes (comma separated list FDA assigned to the subject device)
LBH, EJK, EBC, and EMA
Device Description
GILB-2, Glass Ionomer protective coating is classified as Dental Cement (21 C.F.R§872.3275) because it is a device intended to provide protection as a cavity liner/basing material as well as in treatment of exposed root surfaces hypersensitivity. GILB-2 is a site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions.
GILB-2 is a two part liquid/paste system. The liquid/paste materials are contained in the Clicker™ Dispensing System manufactured by 3M ESPE. This dispensing system provides simultaneous dispensing of each component for a consistent mix.
The chemical composition is similar to predicate glass ionomer dental cement devices. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surfaces, exposed root surfaces
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)
The performance testing results provided in the submission confirms the performance as substantially equivalent to the predicate devices with common indications.
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.
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
§ 872.3275 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
3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110
3M ESPE Dental Products
3M Center Bldg 260-2A-17
Sr. Regulatory Specialist
21 C.F.R. §872.3275 as a Class II device.
November 21, 2007
St. Paul, Mn. 55144
Karen O'Malley
651 736-7326
651 737-6049
Dental Cement
Dental Cement
USA
2110898
GILB-2
ЗЕЗРЕ
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
Company: Street: ZIP-Code, City: Country: Establishment Registration Number: Official Correspondent:
- Phone: Fax: E-mail: Date:
Name of Device
Proprietary Name: Classification Name
Common Name:
Predicate Devices
| Device | 510(k) |
|---|---|
| Vitrebond Plus | K011200 |
| Fuji VII Capsule (Fuji Triage) | K013198 |
| Embrace Wetbond Clear Sealant | K052281 |
Description and Technology Equivalence
GILB-2, Glass Ionomer protective coating is classified as Dental Cement (21 C.F.R§872.3275) because it is a device intended to provide protection as a cavity liner/basing material as well as in treatment of exposed root surfaces hypersensitivity. GILB-2 is a site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions.
GILB-2 is a two part liquid/paste system. The liquid/paste materials are contained in the Clicker™ Dispensing System manufactured by 3M ESPE. This dispensing system provides simultaneous dispensing of each component for a consistent mix.
The chemical composition is similar to predicate glass ionomer dental cement devices. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.
The performance testing results provided in the submission confirms the performance as substantially equivalent to the predicate devices with common indications.
JAN 1 7 2008
073395
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2008
Ms. Karen O'Malley Senior, Regulatory Specialist 3M ESPE Dental Products 3M Center, Building 260-2A-17 St. Paul. Minnesota 55144-1000
Re: K073395
Trade/Device Name: GILB-2, Glass Ionomer Protective Coating Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Codes: LBH, EJK, EBC, and EMA Dated: November 21, 2007 Received: December 5, 2007
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.
2
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 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" (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,
Sydtie y. Michin Oms
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
Enclosure
3
Indications for Use
510(k)Number:K073395
Device Name: GILB-2, Glass Ionomer Protective Coating
Text
Indications For Use:
-
- Lining and basing applications under composite, amalgam, ceramic or metal restorations.
-
- Treatment of exposed root surface sensitivity
-
- Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions
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)
Susan Runge
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