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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Outcome Measure	Predicate Device Performance (GC Fuji Ortho™ LC)	GlassLok Device Performance	Acceptance Met?
Performance	Shear Bond Strength (to enamel)	Baseline (not explicitly quantified but used for comparison)	Similar or better than predicate	Yes
	Shear Bond Strength (to metal)	Baseline (not explicitly quantified but used for comparison)	Similar or better than predicate	Yes
	ISO 9917-2:2017 Testing Results	Similar results (to GlassLok)	Similar results (to GC Fuji Ortho™ LC)	Yes
Biocompatibility	Local/Systemic Adverse Effects	Not applicable (predicate not directly evaluated in this context)	No adverse local or systemic effects	Yes
	Carcinogenic/Mutagenic Potential	Not applicable	Not carcinogenic or mutagenic	Yes
	Reproductive/Developmental Effects	Not applicable	No adverse reproductive or developmental effects	Yes
	Cytotoxicity	Not applicable (supplemental for GlassLok)	Passed (implied by overall biocompatibility conclusion)	Yes
	Oral Toxicity	Not applicable (supplemental for GlassLok)	Passed (implied by overall biocompatibility conclusion)	Yes

Explanation of "Acceptance Met?": The document states that GlassLok demonstrated "similar or better performance" for shear bond strength and "similar results" for ISO 9917-2:2017 testing when compared to the predicate. For biocompatibility, it states 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." This indicates the acceptance criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample size used for the shear bond strength testing or the ISO 9917-2:2017 testing.
Data Provenance: The document does not specify the country of origin of the data. It also does not state whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it would most likely be prospective, newly generated data for the purpose of the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document describes laboratory performance testing (shear bond strength, ISO 9917-2:2017) and biocompatibility evaluations, not a study involving human interpretation where "ground truth" would be established by experts in the clinical sense (e.g., radiologists interpreting images).
Therefore, this question is not applicable in the context of this device's evaluation as described. The "ground truth" here is objective physical and chemical measurements.

4. Adjudication Method for the Test Set

As mentioned above, the primary evaluations were laboratory-based performance tests and biocompatibility assessments, not studies requiring expert adjudication of results.
Therefore, this question is not applicable in the context of this device's evaluation as described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done.
This device, GlassLok, is a dental cement, not an AI-powered diagnostic or decision support tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done.
GlassLok is a physical dental material, not an algorithm or software.

7. The Type of Ground Truth Used

For performance testing (shear bond strength, ISO 9917-2:2017): The ground truth was based on objective physical and mechanical measurements obtained through standardized laboratory test methods. The predicate device served as the comparative benchmark.
For biocompatibility: The ground truth was established through biological evaluations and chemical characterization against established international standards (ISO 10993 and ISO 7405:2018), determining whether the material caused adverse biological reactions.

8. The Sample Size for the Training Set

This is a medical device (dental cement), not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI development is not applicable. The device's performance is inherent to its material properties and manufacturing, not learned from data.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" is not applicable for this type of device. The characteristics and performance of GlassLok are determined through its chemical composition and physical properties, which are then verified through the performance data described.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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 630-773-4009 · 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.Paul Gange, President/Owner
Address:	1540 West Thorndale Ave.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:

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 630-773-4009 · 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/Indications forUse	Dual Cure GlassIonomer Band Cement	Light Cure OrthodonticBonding Adhesive /Glass Ionomer dentalcement.
ChemicalComposition	Resin Modified GlassIonomer Powder /Methacrylate basedliquid	Resin Modified GlassIonomer Powder /Methacrylate basedliquid
ProductFeatures	Bonds to metal andenamel surfaces.Band cementBonds in a wet fieldContains FluorideBiocompatible	Bonding metal bracketsand attachments.Band cementation onlywhen extra bandretention is desiredBonds in a wet fieldFluoride releasingBiocompatible
Shelf Life	2 years at roomtemperature	2 years at roomtemperature
DispensingMethod	Bottle – Powder / Liquid	Bottle – Powder / Liquid
Method of Cure	Dual Cure (Light Cureand Chemical Cure)	Triple-Cure (ChemicalCure / Light Cure / AcidBased)

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 630-773-4009 · 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.

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
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.(b)
Classification. Class II.