Flowtain™ is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers and splinting materials, creation of archwire stops and indirect bonding of orthodontic brackets. Flowtain™ can also be used for the retention of thermoplastic aligners.

Flowtain™ LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.

Device Description

Flowtain™ is a light-cure orthodontic adhesive with a low modulus of elasticity that is flowable. This low modulus of elasticity makes it ideal for bonding lingual retainers, splinting materials and for indirect bonding of brackets. Thixotropic design properties of Flowtain™ also make it highly polishable which allows it to be used for comfortable archwire stops and as an aid for retention of a thermoplastic aligner.

Flowtain™ LV is a low viscosity version of the Flowtain™ product used primarily for indirect bonding of brackets.

Both are available in push syringe or tips for preferences in dispensing.

AI/ML Overview

The provided text describes the 510(k) summary for "Flowtain™ and Flowtain™ LV," orthodontic adhesives. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining and proving acceptance criteria for a novel AI or software device. As such, many of the requested categories for AI/software device evaluation are not directly applicable or explicitly stated in the document.

However, I can extract and infer information relevant to the device's performance evaluation as presented:

Acceptance Criteria and Study for Flowtain™ and Flowtain™ LV

The acceptance criteria for Flowtain™ and Flowtain™ LV relate to demonstrating comparable performance, specifically in shear bond strength, to the legally marketed predicate device, 3M Unitek Transbond™ Supreme LV. The study aimed to show similar performance between the new devices and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Shear Bond Strength	Similar performance to 3M Unitek Transbond™ Supreme LV.	Testing "resulted in similar performance between the two adhesives."
Toxicity	Non-toxic.	"Flowtain™ has been tested and proven to be non-toxic."

2. Sample Size and Data Provenance

Sample Size for Test Set: Replicates of 5 for Flowtain™, Flowtain™ LV, and Transbond™ Supreme LV. (Total of 15 samples for shear bond strength testing, assuming 5 replicates for each of the three products).
Data Provenance: Not explicitly stated, but the testing method ("in-vivo performance test method") suggests biological or simulated biological conditions. The manufacturer is based in Itasca, Illinois, USA, implying the study was likely conducted in the USA. The study design (comparison against a predicate device) is typical for a 510(k) submission. It's a retrospective comparison against a known predicate device's performance data or a prospective comparative study where both were tested simultaneously under the same conditions. Given the phrasing "tested against," it implies a comparative study.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of device. The assessment of shear bond strength is a quantitative mechanical test, not dependent on expert interpretation or ground truth established by human experts in the way an image analysis or diagnostic AI would require.

4. Adjudication Method

Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on qualitative assessments (e.g., medical image interpretation). Shear bond strength is a physical measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. Flowtain™ and Flowtain™ LV are orthodontic adhesive materials, not AI systems.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This relates to AI algorithms. The performance of the adhesive materials was evaluated directly through mechanical testing.

7. Type of Ground Truth Used

Mechanical Test Results / Physical Property Measurement: The "ground truth" for shear bond strength is the objective measurement obtained from a standardized mechanical test. For toxicity, it's based on toxicology testing.

8. Sample Size for Training Set

Not applicable. This device is a physical product (orthodontic adhesive), not a machine learning model, so there is no "training set."

9. How Ground Truth for Training Set was Established

Not applicable. As there is no training set for an AI model, this question is irrelevant to the described device.

Summary of the Study:

The study detailed in the 510(k) summary for Flowtain™ and Flowtain™ LV involved in-vivo performance testing to assess shear bond strength. This testing was conducted using an indirect bonding procedure for replicates of 5 for Flowtain™, Flowtain™ LV, and the predicate device, 3M Unitek Transbond™ Supreme LV. The results indicated that the new adhesives achieved "similar performance" to the predicate device, thereby meeting the implied acceptance criterion for substantial equivalence in this critical mechanical property. Additionally, Flowtain™ was explicitly tested and proven to be non-toxic.

Summary

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Reliance Or hodonlic Prod

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 · Itasca, IL · 60143 · U.S.A.

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Section 5.0

510 (k) Summary

FEB 2 0 2009

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

510 (k) Owners Name: Reliance Orthodontic Products, Inc. Paul Gange, President

Address:

1540 West Thorndale Avenue Itasca, Il 60143 USA

Phone Number: 630-773-4009 630-250-7704 Fax Number:

Paula Wendland, Regulatory Affairs Manager (Preparer) Contact Person:

Date 510 (k) Summary was Prepared: October 10, 2008

Medical Device Name:

Trade name Flowtain™ and Flowtain™ LV
Common name Flowable Light Cure Orthodontic Adhesive ◆
Classification name Bracket Adhesive Resin and Tooth Conditioner (21CFR872.3750. Product Code DYH, Class II Device)

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

3M Unitek Transbond™ Supreme LV
Bisco Inc. TESCERAFLOTM

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Reliance Orthodontic Products, Inc.

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 · Itasca, IL · 60143 · U.S.A.

5.1 DESCRIPTION OF THE APPLICANTS DEVICE:

Flowtain™ LV is a low viscosity version of the Flowtain™ product used primarily for indirect bonding of brackets.

Both are available in push syringe or tips for preferences in dispensing.

5.2 INTENDED USE AND POPULATION:

Flowtain™ LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.

5.3 PREDICATE DEVICE:

3M Unitek Transbond™ Supreme LV, 510(k) submission (K073697) dated 02/15/2008 for intended use.

Flowtain™ and Flowtain™ LV are similar in composition as Bisco Inc. TESCERAFLO™, 510(k) submission (K030951) for safety and performance.

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Image /page/2/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a stylized "R" enclosed in a circle above the company name. The text "Reliance Orthodontic Products, Inc." is written in a cursive font. The logo is black and white.

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 - Itasca, IL - 60143 · U.S.A.

5.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:

Performance Characteristics of Flowtain™ versus Transbond™ Supreme LV:

Property	Flowtain	Transbond Supreme LV
Intended Use	Flowable Light Cureadhesive for bonding lingualretainers and indirectbonding of orthodonticbrackets	Flowable Light Cure Adhesive forindirect bonding of orthodonticbrackets and bonding to enamelsurfaces.
Mechanical /PhysicalProperties	Single paste in a hand-helddelivery system.	Single paste in a hand-helddelivery mechanism.
	Flowable Composite	Flowable Composite

Performance Characteristics of Flowtain™ and Flowtain™ LV versus TESCERAFLO TM:

Property	Flowtain™ and Flowtain™ LV	TESCERAFLO™
Intended	Flowable Light Cure adhesive	Flowable Light Cure adhesive
Use	for direct and indirect bonding	for direct or indirect restorations
Chemical	Ethoxylated Bisphenol A	Ethoxylated Bisphenol A
Composition	Dimethacrylate	Dimethacrylate
	Triethyleneglycol	Triethyleneglycol
	Dimethacrylate	Dimethacrylate
	Glass Filler	Glass Filler

5.5 Summary:

Flowtain™ and Flowtain LV were tested against Transbond™ Supreme LV using in-vivo performance test method for shear bond strength. Testing was conducted using indirect bonding procedure in replicates of 5 for Flowtain™, Flowtain™ LV and Transbond™ Supreme LV, the predicate device. Testing resulted in similar performance between the two adhesives.

Flowtain™ has been tested and proven to be non-toxic.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, line-art style, and the text is in a sans-serif font.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2009

Ms. Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products, Incorporated 1540 West Thorndale Avenue Itasca. Illinois 60143

· Re: . K083051

Trace/Device Name: Flowtain™ and Flowtain™ LV Regulation Number: 21CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH, EBF Dated: February 13, 2009 Received: February 17, 2009

Dear Ms. 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. The gewinels provisions@fothe.Act include requirements for annual registration, baling of devices, good manufacturung practice, say 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 1 Register.

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Page 2 - Ms. Wendland

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

so June Ginette Y. Michaud, M.D. Acting 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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Reliance Orthodontic Products, Inc.

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 - Itasca, IL . 60143 . U.S.A.

SECTION 6.0 INDICATIONS FOR USE STATEMENT

Indications for Use

510 (k) Number (if known):

Flowtain™ and Flowtain™ LV Device Name:

Indications for Use:

Flowtain™ LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Sura Guoro

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 465305

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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.