GlassLok Kits, GlassLok Powder, GlassLok Liquid

K193388 · Reliance Orthodontic Products, Inc. · DYH · Apr 27, 2020 · Dental

Device Facts

• Record ID: K193388
• Device Name: GlassLok Kits, GlassLok Powder, GlassLok Liquid
• Applicant: Reliance Orthodontic Products, Inc.
• Product Code: DYH · Dental
• Decision Date: Apr 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.

Device Story

GlassLok is a dual-cure resin-modified glass ionomer cement used by orthodontists or dentists to bond molar bands to enamel or metal substrates. The device is supplied as a two-part system (powder and liquid) mixed at a 2:1 ratio on a mixing pad. The material is hydrophilic, allowing for use in wet or dry fields. Once applied to the band and tooth, it sets chemically within 5 minutes or can be light-cured for 20 seconds. Available in natural or blue shades for visibility during removal. The device provides a mechanical bond to tooth and metal surfaces; it is intended for professional use in clinical settings.

Clinical Evidence

Bench testing only. Performance evaluated via shear bond strength testing against predicate GC Fuji Ortho LC on enamel and metal substrates. Additional testing conducted per ISO 9917-2:2017. Biocompatibility assessed per ISO 10993 and ISO 7405:2018, including cytotoxicity and oral toxicity testing, confirming no adverse local or systemic effects.

Technological Characteristics

Resin-modified glass ionomer cement; powder/liquid formulation. Methacrylate-based liquid. Dual-cure (chemical and light-cure). Hydrophilic properties. Biocompatible. Tested per ISO 9917-2:2017, ISO 10993, and ISO 7405:2018. Shelf life: 2 years at room temperature.

Indications for Use

Indicated for use as a dual cure glass ionomer band cement for bonding molar bands to enamel or metal substrates in orthodontic or dental office settings.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Predicate Devices

• GC Fuji Ortho LC (K981461)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a blue square.

April 27, 2020

Reliance Orthodontic Products Inc. Paula Wendland Regulatory Affairs Manager 1540 West Thorndale Ave. Itasca, Illinois 60143

Re: K193388

Trade/Device Name: GlassLok Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: Class II Product Code: DYH Dated: February 25, 2020 Received: February 27, 2020

Dear Paula Wendland:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas ''Nandu'' Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

#### K193388

Device Name GlassLok

#### Indications for Use (Describe)

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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## PAGE 53

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#### K193388

Image /page/3/Picture/1 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo consists of a circular emblem with the letter "R" inside, followed by the company name written in a cursive font. A horizontal line underlines the company name, adding a touch of elegance to the overall design.

48 · Phone [phone] · Fax 630

#### Section 5.0 510 (k) Summary

Note: This summary is provided in accordance with 21CFR807.92.

| 510(k) Submitter: | Reliance Orthodontic Products, Inc.<br>Paul Gange, President/Owner |
|-------------------|--------------------------------------------------------------------|
| Address: | 1540 West Thorndale Ave.<br>Itasca, IL 60143 USA |
| Phone Number: | 630-773-4009 |
| Fax Number: | 630-250-7704 |
| Contact Person: | Paula Wendland, Regulatory Affairs Manager |

Date 510(k) Summary was Prepared: 12/4/2019

Medical Device Name:

- Trade name GlassLok .
- Common name Dual Cure Band Cement .
- Classification name -Dental Cement (21CFR872.3275, Product Code . EMA, Class II Device)

## LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:

GC Fuji Ortho LC 510(k) K981461 . This predicate has not been subject to a design related recall.

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## K193388

Image /page/4/Picture/1 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem with the letter "R" inside, followed by the company name in an elegant, cursive font. A horizontal line underlines the company name, adding a touch of sophistication to the overall design.

Box 678 1540 West Thorndale Ave · Itaso

### 5.1 DESCRIPTION OF THE APPLICANTS DEVICE:

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. GlassLok can be used to bond molar bands to an enamel or metal substrate in a wet or dry field due to its hydrophilic properties. GlassLok is available in natural or blue shade (for easy disclosure at removal).

GlassLok is dispensed in a 2 part (powder and liquid) format with bottle dispensing. A 15cc and 25 cc liquid (in blue or natural shade) along with a 15gm or 100gm powder component will be available as separate components. A convenience kit will also be available in Blue or Natural shade in a starter or economy volume.

GlassLok powder is dispensed to a mixing pad using a measuring scoop and mixed with GlassLok liquid in a ratio of 2:1. The mixed GlassLok composite is then applied to the inside of an orthodontic band and applied to a properly prepared tooth structure. Working Time is 2 minutes and setting time is 5 minutes once the working time has expired. GlassLok can also be cured with a curing light for 20 seconds, if required for polymerization.

Associated accessories include a measuring scoop. Spatula and mixing pad.

## 5.2 INDICATIONS FOR USE AND POPULATION:

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.

#### 5.3 PREDICATE DEVICE:

GC Fuji Ortho™ LC 510(k) submission (K981461) dated 06/25/1998 is similar in intended use, handling and technology compared to the device described in this submission.

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#### K193388

Image /page/5/Picture/1 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem with the letter "R" inside, followed by the company name in a stylized font. A horizontal line underlines the company name, adding a touch of elegance to the overall design.

Toll Free 1-800 323-4348 · Phone [phone] · Fax 630-2 P.O. Box 678, 1540 West Thorndale Ave. · Itasca, IL

5.4 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

| Property | GlassLok | Fuji OrthoTM LC |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for<br>Use | Dual Cure Glass<br>Ionomer Band Cement | Light Cure Orthodontic<br>Bonding Adhesive /<br>Glass Ionomer dental<br>cement. |
| Chemical<br>Composition | Resin Modified Glass<br>Ionomer Powder /<br>Methacrylate based<br>liquid | Resin Modified Glass<br>Ionomer Powder /<br>Methacrylate based<br>liquid |
| Product<br>Features | Bonds to metal and<br>enamel surfaces.<br>Band cement<br><br>Bonds in a wet field<br>Contains Fluoride<br>Biocompatible | Bonding metal brackets<br>and attachments.<br>Band cementation only<br>when extra band<br>retention is desired<br>Bonds in a wet field<br>Fluoride releasing<br>Biocompatible |
| Shelf Life | 2 years at room<br>temperature | 2 years at room<br>temperature |
| Dispensing<br>Method | Bottle – Powder / Liquid | Bottle – Powder / Liquid |
| Method of Cure | Dual Cure (Light Cure<br>and Chemical Cure) | Triple-Cure (Chemical<br>Cure / Light Cure / Acid<br>Based) |

#### 5.5 PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

GlassLok was tested against GC Fuji Ortho™ LC using a performance test method for shear bond strength. Testing resulted in similar or better

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# K193388 SECTION 5.0

Image /page/6/Picture/1 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem with the letter "R" inside, followed by the company name in a stylized font. The text is underlined, giving it a classic and professional appearance. The overall design is clean and elegant, conveying a sense of quality and reliability.

Free 1-800-323-4348 · Phone [phone] · Fax 630-2 P.O. Box 678, 1540 West Thorndale Ave. · Itasca, IL · 60143

performance of GlassLok when compared to GC Fuji Ortho LC for shear bond strength to enamel and metal.

In addition, testing per ISO 9917-2:2017 was conducted on both GlassLok and GC Fuji Ortho LC resulting in similar results between the two products.

A biocompatibility evaluation was also conducted in accordance with ISO 10993 and ISO 7405:2018 for the composition of the GlassLok device and determined that the device did not directly or through the release of material constituents produce adverse local or systemic effects; it is not carcinogenic or mutagenic, and will not produce adverse reproductive or developmental effects. As a supplement to the biocompatibility evaluation, both cytotoxicity and oral toxicity testing was conducted on GlassLok.

## 5.6 CONCLUSION:

Based on nonclinical testing conducted for shear bond strength and testing conducted per ISO 9917-2:2017 resulting in similar performance, substantial equivalence was demonstrated between the GlassLok and the GC Fuji Ortho LC devices. In conjunction with biocompatibility demonstrated via ISO 7405:2018 and ISO 10993 evaluations, evidence has been submitted to demonstrate GlassLok is safe and equivalent to or better than the GC Fuji Ortho LC device in terms of performance as a band cement.