(191 days)
No
The summary describes a light-cured primer with a specific chemical composition and mentions only bench testing for mechanical properties and biocompatibility. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No.
The device is a primer/sealant used to prepare the tooth surface for bonding orthodontic appliances, which is a preparatory step rather than a direct therapeutic intervention for a disease or condition.
No
This device is a light cure primer/sealant used to prepare tooth surfaces for bonding orthodontic appliances. Its function is to facilitate the bonding process, not to diagnose a condition or disease.
No
The device description clearly states it is a "light cured orthodontic sealant" and mentions "mechanical properties" and "Bond Strength Testing," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prepare the tooth surface prior to bonding orthodontic appliances to etched enamel." This is a direct application to the patient's tooth for a therapeutic/restorative purpose (facilitating orthodontic bonding), not for testing a sample in vitro to diagnose a condition.
- Device Description: The description confirms it's a "light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding." This aligns with the intended use and doesn't suggest any diagnostic function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the FiteBac® CC OrthoSeal with K18 QAMS is a medical device used in a clinical setting for a dental procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surface / etched enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing - Bench Study Comparison:
The subject device has mechanical properties substantially equivalent to commercially available devices with the same intended uses. The following characteristics were evaluated:
Performance Testing:
- Bond Strength Testing
Non-clinical Testing - Biocompatibility: - Sensitization
- Cytotoxicity
- Irritation
Testing Summary: Results of all conducted testing was found acceptable and do not raise any new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 29, 2021
Largent Health, LLC % Elizabeth O'Keeffe Regulatory Affairs Director Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K210115
Trade/Device Name: FiteBac CC OrthoSeal Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket adhesive resin and tooth conditioner Regulatory Class: Class II Product Code: DYH Dated: May 28, 2021 Received: June 1, 2021
Dear Elizabeth O'Keeffe:
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page.
510(k) Number (if known) K210115
Device Name
FiteBac® CC OrthoSeal
Indications for Use (Describe)
FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
PSC Publishing Services(301)443-6740 EF
3
510(k) SUMMARY: FiteBac® CC OrthoSeal (K210115)
Company Name:
Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 Phone: 770-218-6221
Date Prepared: July 28, 2021
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
-
- General Information:
Applicant Name: Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 Phone: 770-218-6221 Establishment Registration Number: 3015709927
- General Information:
2. Contact Person:
Elizabeth O'Keeffe, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com
Secondary Contact:
Patricia D. Jones, VP of Regulatory Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 Requlatory@SecureBME.com
-
- Device Name and Classification: Trade Name: Classification Name:
Common Name: Classification Panel: Regulation Number: Device Class: Product Codes:
- Device Name and Classification: Trade Name: Classification Name:
FiteBac® CC OrthoSeal Bracket adhesive resin and tooth conditioner Adhesive. Bracket and Tooth Conditioner Dental 21 CFR §872.3750 DYH
4
Orthodontic
- Primary Predicate Device: Ultradent Opal® Seal™ Trade Name: 510(k) Clearance: K090355 April 29, 2009 Clearance Date: Classification Name: Bracket adhesive resin and tooth conditioner Common Name: Adhesive, Bracket and Tooth Conditioner Dental Classification Panel: 21 CFR §872.3750 Regulation Number: Device Class: Product Codes: DYH Predicate Device: Trade Name: Transbond Light Cured Adhesive (Transbond XT Primer) 510(k) Clearance: K880393 March 31, 1988 Clearance Date: Bracket adhesive resin and tooth Classification Name: conditioner Common Name: Adhesive, Bracket and Tooth Conditioner Dental Classification Panel: Regulation Number: 21 CFR §872.3750 Device Class: Product Codes: DYH Reference Device: Orthodontic Acrylic 2 Trade Name: K163482 510(k) Clearance: May 31, 2017 Clearance Date: Classification Name: Denture relining, repairing, or rebasing resin. Classification Panel: Dental Regulation Number: 21 CFR §872.3760 Device Class: . EBI Product Codes:
5. Device Description:
The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.
Technological Characteristics:
5
The subject device has substantially equivalent technological characteristics as the predicate devices and/or the reference device in terms of principles of operation, intended use, material performance, and biocompatibility.
6. Indications for Use:
FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
7. Substantial Equivalence:
FiteBac® CC OrthoSeal has the same intended use, principles of operation and substantially equivalent technological characteristics as Ultradent's Opal® Seal™ (K090355). Although FiteBac® CC OrthoSeal differs from the predicate devices in the presence of K18 QAMS. FiteBac® CC OrthoSeal and the reference device Lang Orthodontic Acrylic 2 both contain this same K18 QAMS compound. Both the subject device and the predicate devices have been shown to prime teeth surfaces without negatively effecting the bond strength of orthodontic adhesives. FiteBac® CC OrthoSeal is as safe and effective as the predicate and reference comparator devices currently cleared for marketing in the United States. Additional biocompatibility and non-clinical testing demonstrate FiteBac® CC OrthoSeal is as safe and effective as these devices and does not raise additional questions of safety and effectiveness.
-
- Comparison of Technological Characteristics with the Predicate devices: A comparison of the subject device to the predicate devices and reference device is shown in the following table.
| Characteristics | Subject Device
FiteBac® CC
OrthoSeal | Primary Predicate
Ultradent Opal®
Seal™
K090355 | Predicate Device
Transbond Light
Cured Orthodontic
Adhesive (Transbond
XT Primer)
K0880393 | *Reference Device
Lang Orthodontic
Acrylic 2
K163482 | Comparison
Results |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------|
| Indication for
Use Statement | FiteBac® CC OrthoSeal
with K18 QAMS is a
light cure primer
intended to prepare the
tooth surface prior to
bonding orthodontic
appliances to etched
enamel. | Opal® Seal is a
light cure primer
that is used when
bonding orthodontic
appliances to
etched enamel. | N/A | N/A | Comparable |
| Principle of
Operation | Methacrylate Sealant | Methacrylate
Sealant | Methacrylate Sealant | Methacrylate-based
material | Equivalent to
predicates |
| Available
Configurations | Liquid | Liquid in a single
barrel syringe | Liquid | Liquid and Powder | Equivalent to
predicate
devices |
| Size | 6 mL | 1.2- or 3-mL
Syringe | 6 mL | Multiple Sizes | Equivalent to
secondary
predicate
device |
| Package | Polyethylene Bottles | NA | Polyethylene Bottles | Polyethylene
Bottles | Equivalent to
secondary
predicate
device |
6
Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064
| Characteristics | Subject Device
FiteBac® CC
OrthoSeal | Primary Predicate
Ultradent Opal®
Seal™
K090355 | Predicate Device
Transbond Light
Cured Orthodontic
Adhesive (Transbond
XT Primer)
K0880393 | *Reference Device
Lang Orthodontic
Acrylic 2
K163482 | Comparison
Results |
|-----------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------|
| Biocompatibility | Yes - see table 12.2.1 | Yes | Yes | Yes | Equivalent to
predicate
devices |
| CC OrthoSeal Light Curing Specification Comparison with Ultradent Opal® Seal™ (K090355) | | | | | |
| Characteristics | | Subject Device
FiteBac® CC OrthoSeal
K210115 | | Primary Predicate
Ultradent Opal® Seal™
K090355 | |
| Time to Cure | | 10 seconds | 20 seconds | 20 seconds | 10 seconds |
| Wavelength | |