GILB-2, GLASS IONOMER PROTECTIVE COATING

K073395 · 3M Espe Dental Products · EMA · Jan 17, 2008 · Dental

Device Facts

• Record ID: K073395
• Device Name: GILB-2, GLASS IONOMER PROTECTIVE COATING
• Applicant: 3M Espe Dental Products
• Product Code: EMA · Dental
• Decision Date: Jan 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

1. Lining and basing applications under composite, amalgam, ceramic or metal restorations. 2. Treatment of exposed root surface sensitivity 3. Site specific protective coating for newly erupted teeth and other tooth surfaces including non-cavitated lesions

Device Story

GILB-2 is a glass ionomer protective coating used as a cavity liner/base or for root surface hypersensitivity treatment. It is a two-part liquid/paste system delivered via the 3M ESPE Clicker™ Dispensing System, which ensures simultaneous dispensing and consistent mixing. The device is applied by dental professionals in a clinical setting. It functions as a site-specific protective barrier for tooth surfaces, including newly erupted teeth and non-cavitated lesions. By providing a protective layer, it aids in managing sensitivity and protecting tooth structure under various restorative materials (composite, amalgam, ceramic, metal).

Clinical Evidence

Bench testing only. Biocompatibility assessment conducted according to ISO 10993 and ISO 7405. Performance testing confirmed substantial equivalence to predicate devices.

Technological Characteristics

Two-part liquid/paste glass ionomer system. Delivered via 3M ESPE Clicker™ Dispensing System. Biocompatibility compliant with ISO 10993 and ISO 7405.

Indications for Use

Indicated for patients requiring cavity lining/basing under restorations, treatment of exposed root surface hypersensitivity, or protective coating for newly erupted teeth and non-cavitated lesions.

Regulatory Classification

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. 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.

Predicate Devices

• Vitrebond Plus (K011200)
• Fuji VII Capsule (Fuji Triage) (K013198)
• Embrace Wetbond Clear Sealant (K052281)

Submission Summary (Full Text)

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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

[e-mail]

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

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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.

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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 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 [phone]. 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 [phone] or [phone] 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

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# Indications for Use

510(k)Number:K073395

Device Name: GILB-2, Glass Ionomer Protective Coating

Text

## Indications For Use:

- 1. Lining and basing applications under composite, amalgam, ceramic or metal restorations.
- 2. Treatment of exposed root surface sensitivity
- 3. 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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