(79 days)
The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive.
The Reliance S.E.P. is a one step self etching primer contained in a handheld dispenser. Upon manual compression into a light impervious mixing well, enough solution is dispensed to prepare the enamel surface of up to 20 teeth.
The provided document describes the Reliance S.E.P. (Self Etching Primer) and its substantial equivalence to a predicate device, 3M Unitek Transbond Plus Self Etching Primer. The primary study conducted to demonstrate this equivalence is a "Shear bond strength testing comparison."
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence in Effectiveness (Shear Bond Strength) | The Reliance S.E.P. demonstrates equivalence to the legally marketed predicate device (3M Unitek Transbond™ Plus Self Etching Primer) in terms of effectiveness, as shown by shear bond strength testing comparisons. |
| Non-toxicity | The device was found to be non-toxic based on an Oral Toxicity Test method. |
Note: The document states that the acceptance criterion for effectiveness is equivalence to the predicate device's effective bond strength, but it does not provide specific numerical thresholds or performance targets for either device's bond strength. It simply states that the Reliance S.E.P. "demonstrate[s] that the applicant device is equivalent to the legally marketed device in terms of effectiveness."
Study Details
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for the shear bond strength testing.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the type of study conducted. The ground truth for this performance study (shear bond strength testing) would be objective measurements of bond strength, not expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective human assessment (e.g., image interpretation). This is a physical/mechanical performance study, so such adjudication is not applicable. The measurements would be objective.
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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 is a self-etching primer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable. The device is a physical product (self-etching primer), not an algorithm. The "standalone" performance here refers to the device's inherent mechanical properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for effectiveness was based on objective mechanical/physical measurements of shear bond strength. For safety, it was an Oral Toxicity Test method.
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The sample size for the training set:
- This information is not applicable. This is a study of a physical medical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- This information is not applicable, as there is no "training set" in this context.
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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.
SEP - 7 2007
Section 5.0 510 (k) Summary
Note: This summary is provided in accordance with the requirements of 21CFR807.92 (c).
| 510 (k) Owners Name: | Reliance Orthodontic Products, Inc.Paul Gange, President | |
|---|---|---|
| Address: | 1540 West Thorndale AvenueItasca, Il 60143 USA | |
| Phone Number: | 630-773-4009 | |
| Fax Number: | 630-250-7704 | |
| Contact Person: | Paula Wendland, Regulatory Affairs Manager(Preparer) |
Date 510 (k) Summary was Prepared: June 14, 2007
Medical Device Name:
- Trade name Reliance S.E.P. .
- Common name Self Etching Primer .
- Classification name Resin Tooth Bonding Agent (21CFR872.3200, . Product Code KLE, Class II Device)
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:
- 3M Unitek Transbond ™ Plus Self Etching Primer (510(k) submission . K984246 under the ESPE Dental Ag Prompt L-Pop)
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Image /page/1/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo consists of a stylized letter "R" enclosed in a circle, which is positioned above the company name. The company name is written in a cursive font, with the words "Reliance Orthodontic Products" on the first line and "Inc." on the second line. The logo is simple and elegant, and it conveys a sense of professionalism and quality.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 · Itasca, IL · 60143 · U.S.A
DESCRIPTION OF THE APPLICANTS DEVICE:
The Reliance S.E.P. is a one step self etching primer contained in a handheld dispenser. Upon manual compression into a light impervious mixing well, enough solution is dispensed to prepare the enamel surface of up to 20 teeth.
INTENDED USE AND POPULATION:
The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive. The intended patient population ranges from pediatric to adult recipients of orthodontic treatment.
TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:
Performance Characteristics of the Reliance S.E.P. versus the 3M Unitek Transbond ™ Plus Self Etching Primer:
| Property | Reliance S.E.P. | 3M Unitek Transbond™Plus Self EtchingPrimer |
|---|---|---|
| Intended Use | Self Etching Primer,Single Step Delivery foruse with light curebonding orthodonticadhesives | Self Etching Primer,Single Step Deliveryuse with light curebonding orthodonticadhesives. |
| Mechanical / PhysicalProperties | • Combines etchingand priming in oneeasy step• Effective bondstrength | • Combines etchingand priming in oneeasy step• Effective bondstrength |
| Chemical Composition | Acidic Monomer /Solvent | Acidic Monomer /Solvent |
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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, which is positioned above the company name. The company name is written in an elegant, cursive font. The words "Reliance Orthodontic Products, Inc." are all on one line.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 - Itasca, IL - 60143 · U.S.A.
Shear bond strength testing comparisons conducted between the Reliance S.E.P. and the predicate device, 3M Unitek Transbond TM Plus Self Etching Primer demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness.
Additionally, toxicity testing was conducted using an Oral Toxicity Test method and was found to be non toxic. Sufficient data has been generated to demonstrate that the applicant device is safe for its intended use.
Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products, Inc. 800-323-4348 / 630-773-4009 Fax: 630-250-7704
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
SEP - 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products, Incorporated 1540 West Thorndale Avenue Itasca, Illinois 60143
Re: K071688
Trade/Device Name: Reliance S.E.P. Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 24, 2007 Received: August 27, 2007
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 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. 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 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 vours.
Spirite y. Mckinno md
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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Image /page/5/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a stylized "R" inside a circle with a registered trademark symbol. Below the symbol is the company name, "Reliance Orthodontic Products, Inc." in a cursive font.
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): K07 | 1688
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive.
| Prescription Use X(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|
| ---------------------------------------------------------- | -------- | ------------------------------------------------ |
| Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 10(k) Number: | K071688 |
Page - 10 -
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.