(211 days)
Not Found
No
The device description and intended use are focused on chemical etching and bonding agents, with no mention of AI or ML capabilities.
No.
The devices are used for etching, bonding, and activating materials for dental restorations, which are not considered therapeutic interventions to treat diseases or conditions.
No
Explanation: The descriptions for DentoEtch, Quickbond, and Bond Activator consistently define their purpose as preparing surfaces, bonding materials, or enabling self-curing techniques in dental procedures. None of the listed intended uses or device descriptions involve identifying, analyzing, or diagnosing medical conditions.
No
The device description clearly indicates the device is a chemical substance (etching gel, bonding system) and not software.
Based on the provided information, none of these devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended uses of DentoEtch, Quickbond, and Bond Activator are all related to preparing and bonding materials directly to the tooth structure (enamel and dentine) within the patient's mouth. They are not used to analyze samples taken from the body.
- The descriptions focus on the chemical composition and application to the tooth. The descriptions of DentoEtch (etching gel) and Quickbond (bonding system) detail their components and how they are applied to the tooth surface. This is consistent with dental materials used for direct application.
- The intended use is for dental procedures. The indications for use clearly describe procedures performed directly on the tooth, such as etching, bonding, and repairing.
Therefore, these devices fall under the category of dental materials used for direct application in the mouth, not IVDs.
N/A
Intended Use / Indications for Use
Device Name: DentoEtch
Indication for Use: It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites.
Device Name: Quickbond
Indication for Use: It is intended for:
- · Bonding composite to enamel and/or dentin;
- · Bonding veneers, crowns & bridges, onlays and inlays
- · Bonding composite core built-up material
- · Bonding of composite to metal,
- · Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers);
- · Treatment of hypersensitive teeth or exposed root surfaces; and
- · Cavity sealing under amalgam restorations
Device Name: Bond Activator
It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.
Product codes
EBF, KLE
Device Description
DentoEtch: DentoEtch is an etching gel phosphoric acid 37%.
Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth enamel, dentine, teeth, root surfaces
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K000954, K061998, K023842, K982394, K964525, K013543
Reference Device(s)
Not Found
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
K | 22.522
Itena Clinical
510(k) Summary
MAR 1 9 2013
- Name/Address of Submitter:
Contact Person:
Louis-Paul Marin Co-President, BCF Certification inc. Phone: (514) 397-5546 (514) 397-8515 Fax: Email: Ipmarin@bcf.ca
July 24, 2012 3. Date Summary Prepared:
- Devices Names: DentoEtch, Quickbond and Bond Activator 4. 5. Device Classification: II
-
- Common name: Etching Gel and Resin tooth bonding agents
-
- Classification Product Code: EBF (21 CFR 872.3690) and KLE (21 CFR 872.3200)
-
- Predicate Devices:
| DentoEtch | Kerr Gel Etchant
K000954 | | |
|----------------|------------------------------------------------------------|-------------------------------------------|------------------------------------|
| Quickbond | Premier
Self-
Etching
Bond
Enhancer
K061998 | Clearfil
SE Bond
K023842 | Prime
and
Bond NT
K982394 |
| Bond Activator | Prime & Bond
Activator
K964525 | Bond-1 Self-
Cure Activator
K013543 | |
9. Devices Description:
DentoEtch: DentoEtch is an etching gel phosphoric acid 37%.
Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator
1
resulted in cell reactions that have been interpreted as Moderate-severe and none, respectively, validating the test.
- Conclusion Drawn: Based on their indications for use, technological 12. characteristics and comparison to predicate devices, the subject devices have been shown to be safe and effective for their intended use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2013
Itena Clinical C/O Mr. Louis-Paul Marin Co-President BCF Certification Incorporated 500 Boul Cartier West Laval, Canada H7V 5B7
Re: K122522
Trade/Device Name: Quickbond , Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 15, 2013 Received: February 11, 2013
Dear Mr. Marin:
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. Iisting 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.
3
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kwame O. Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K12252z
Indication for Use
Device Name: DentoEtch
Indication for Use:
It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites.
Device Name: Quickbond
Indication for Use:
It is intended for:
- · Bonding composite to enamel and/or dentin;
- · Bonding veneers, crowns & bridges, onlays and inlays
- · Bonding composite core built-up material
- · Bonding of composite to metal,
- · Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers);
- · Treatment of hypersensitive teeth or exposed root surfaces; and
- · Cavity sealing under amalgam restorations
Device Name: Bond Activator
It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.
Concurrence of CDRH Office of Device Evaluation
l - I
| Prescription Use X | OR |
|---|---|
| 801.109) |
| Susan Runner, DDS, MS |
|---|
| Mary S. Runner -S |
| 2013.03.15 |
10:20:07 -04'00'
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
(per 21 CFR
x122 522
510(k) Number:_
Over-the-counter Use