(100 days)
No
The summary describes a chemical primer and its accessories, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on material properties and toxicity.
No
The device is a self-etching primer used to prepare tooth surfaces for orthodontic adhesive, not to treat a disease or condition. Its function is primarily preparatory for a bonding procedure.
No
The device description indicates that Ultra SEP is a "self etching primer" used for "preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive." Its function is to create an "ideal surface for a light cure paste to adhere teeth and brackets." This describes a material used in a therapeutic procedure (orthodontic bonding), not a device that identifies or characterizes a disease or condition for diagnosis.
No
The device description clearly states it is a "self etching primer," which is a chemical substance dispensed from a bottle and applied with a microbrush. This is a physical material, not software.
Based on the provided information, the Ultra SEP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the preparation of an enamel surface prior to bonding with an orthodontic adhesive. This is a preparatory step for a dental procedure performed directly on the patient's teeth.
- Device Description: The description details a primer applied to the tooth surface.
- Anatomical Site: The anatomical site is the enamel surface of teeth, which is part of the patient's body.
- Lack of In Vitro Testing: The description of performance studies focuses on shear bond strength testing and toxicity testing, which are relevant to the device's function and safety when applied to teeth, not on analyzing samples outside the body.
- No Mention of Biological Samples: There is no indication that the device is used to test or analyze biological samples (like blood, urine, tissue, etc.) in a laboratory setting.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ultra SEP device does not fit this description. It is a dental material used directly on the patient's teeth as part of an orthodontic procedure.
N/A
Intended Use / Indications for Use
Ultra SEP is a self etching primer intended to be used for the preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive.
Product codes
KLE
Device Description
Ultra SEP is a self etching primer which can etch up to 6 teeth with a single drop. The material is dispensed from a bottle into a light impervious mixing well, and transferred to teeth by a saturated microbrush. Ultra SEP creates an ideal surface for a light cure paste to adhere teeth and brackets for orthodontic treatment.
Ultra SEP is used in combination with a light impervious mixing well (SEPW) and microbrushes (MB).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel surface (teeth)
Indicated Patient Age Range
Adults and Pediatrics.
Intended User / Care Setting
Orthodontic or Dental Office professional use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Shear bond strength testing comparisons conducted between the Reliance Orthodontics Ultra SEP, the predicate device 3M Unitek Transbond™ Plus Self Etching Primer, and the reference Reliance Orthodontics S.E.P. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing was determined to be unnecessary with the approval of all non-clinical testing, based on the nonclinical testing conducted and equivalency in characteristics demonstrated between Reliance Ultra SEP and 3M Unitek Transbond 110 Plus Self Etching Primer devices. In conjunction with biocompatibility demonstrated via ISO 7405 and ISO 10993-5 evaluations, evidence has been submitted to demonstrate Reliance Ultra SEP is safe and equivalent to or better than the 3M Unitek Transbond™ Plus Self Etching Primer (K984246) device in terms of performance as an Orthodontic Self Etching Primer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2021
Reliance Orthodontic Products, Inc Brian Dean Biomedical Engineering Consultant Cook Device Solutions 7640 Delaine Ct Indianapolis, Indiana 46254
Re: K210945
Trade/Device Name: Ultra SEP Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: May 12, 2021 Received: May 13, 2021
Dear Brian Dean:
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
1
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); 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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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SECTION 6.0
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210945
Device Name Ultra SEP
Indications for Use (Describe)
Ultra SEP is a self etching primer intended to be used for the preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D) [] Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5.0 - 510 (k) Summary
K210945
Image /page/3/Picture/2 description: The image shows the logo for Reliance Orthodontic Products. The logo consists of a circular icon with the letter "R" inside, followed by the word "RELIANCE" in bold, sans-serif font. Below the word "RELIANCE" are the words "ORTHODONTIC PRODUCTS" in a smaller, sans-serif font.
Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA Phone: (630) 773-4009 | Website: www.relianceorthodontics.com
Submitter Information:
Date of 510(k) Summary: 3/19/2021 Submitter: Reliance Orthodontics Products Inc. Preparer and Contact Name: Brian Dean, BME Consultant 510(k) Owner: Paul Gange, President Address: 1540 West Thorndale Ave. Itasca, IL 60143 USA Phone: 630-773-4009 / Fax: 630-250-7704
Email: bdean@cookds.com Email: pgange(@relianceorthodontics.com
Device Name and Classification:
| Common Name of Device: | Self Etching Primer |
|---|---|
| Device Proprietary Name: | Ultra SEP |
| Classification Panel: | Dental |
| Classification Number: | 872.3200 |
| Classification Name: | Resin Tooth Bonding Agent |
| Class: | II |
| Product Code: | KLE |
Substantial Equivalence:
Legally marketed devices to with equivalence is claimed:
- 3M Unitek Transbond™ Plus Self Etching Primer 510(k) (Submitted to FDA as K984246 Prompt L-. Pop by Espe Dental AG)
Device Description
Ultra SEP is a self etching primer which can etch up to 6 teeth with a single drop. The material is dispensed from a bottle into a light impervious mixing well, and transferred to teeth by a saturated microbrush. Ultra SEP creates an ideal surface for a light cure paste to adhere teeth and brackets for orthodontic treatment.
Ultra SEP is used in combination with a light impervious mixing well (SEPW) and microbrushes (MB).
Indications for Use and Population:
Intended Use: Ultra SEP is a self etching primer intended to be used for the preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive.
Diseases/Conditions for diagnosis, treatment, prevention, cure, or mitigation: None
Population: Adults and Pediatrics. Orthodontic or Dental Office professional use.
Predicate Device:
- 3M Unitek Transbond 100 Plus Self Etching Primer 510(k) K984246 dated 11/17/1998 is similar in intended use, ● handling and technology compared to the device described in this 3M product is considered the primary predicate.
- Reliance S.E.P. 510(k) K071688 dated 08/24/2007 is similar in intended use, handling and technology compared . to the device described in this submission; this Reliance Orthodontics product is considered a reference.
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SECTION 5.0 - 510 (k) Summary
Image /page/4/Picture/1 description: The image shows the logo for Reliance Orthodontic Products. The logo consists of a circular symbol with the letter "R" inside, followed by the word "RELIANCE" in bold, uppercase letters. Below the word "RELIANCE" are the words "ORTHODONTIC PRODUCTS" in smaller, uppercase letters.
Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA Phone: (630) 773-4009 | Website: www.relianceorthodontics.com
Comparison of Technological Characteristics with the Predicate Device:
| Submission | Reliance Orthodontics
Ultra SEP | 3M Unitek TransbondTM Plus
Self Etching Primer | Reliance Orthodontics
S.E.P. |
|-------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Classification | Class II, KLE, 21CFR872.3200 | Class II, KLE, 21CFR872.3200 | Class II, KLE, 21CFR872.3200 |
| Intended Use | Self Etching Primer, Single Step
Delivery for use with light cure
bonding orthodontic adhesives | Self Etching Primer, Single Step
Delivery for use with light cure
bonding orthodontic adhesives | Self Etching Primer, Single Step
Delivery for use with light cure
bonding orthodontic adhesives |
| Device
Description | • Combines etching and priming
in one easy step
• Effective bond strength | • Combines etching and priming
in one easy step
• Effective bond strength | • Combines etching and priming
in one easy step
• Effective bond strength |
| Chemical
Composition | Acidic Monomer / Solvent | Acidic Monomer / Solvent | Acidic Monomer / Solvent |
| Dispensing | Boston Round Bottle with
Dropper Cap | A single-patient use foil pack
contains pre-measured etchant and
light cure primer. | A multi-patient use hand-held
dispenser with SEP filled cartridge. |
| Sterilization | Non-Sterile | Non-Sterile | Non-Sterile |
Non-Clinical Data Submitted
Shear bond strength testing comparisons conducted between the Reliance Orthodontics Ultra SEP, the predicate device 3M Unitek Transbond™ Plus Self Etching Primer, and the reference Reliance Orthodontics S.E.P. 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.
Conclusions
Clinical testing was determined to be unnecessary with the approval of all non-clinical testing, based on the nonclinical testing conducted and equivalency in characteristics demonstrated between Reliance Ultra SEP and 3M Unitek Transbond 110 Plus Self Etching Primer devices. In conjunction with biocompatibility demonstrated via ISO 7405 and ISO 10993-5 evaluations, evidence has been submitted to demonstrate Reliance Ultra SEP is safe and equivalent to or better than the 3M Unitek Transbond™ Plus Self Etching Primer (K984246) device in terms of performance as an Orthodontic Self Etching Primer.