(89 days)
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No
The summary describes a chemical primer/conditioner for dental bonding, with no mention of AI or ML technologies.
No
The device is a ceramic primer/conditioner used for bonding dental materials to tooth structures, which is not a therapeutic function.
No
Explanation: The device is described as a ceramic primer/conditioner used for bonding various ceramic materials to tooth substrates and for repairs. Its function is to facilitate adhesion, not to diagnose a medical condition or disease.
No
The device is a chemical primer/conditioner, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that "Interface™" is a ceramic primer/conditioner used to bond dental materials (ceramic, dentin, enamel) together. It is applied directly to these substrates in the mouth.
- Lack of Biological Sample Testing: There is no mention of this device being used to test biological samples taken from a patient. Its function is purely related to the physical and chemical bonding of dental materials.
Therefore, "Interface™" falls under the category of a dental device used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Interface™ is a ceramic primer/ conditioner, which allows the clinician to bond any type of ceramic (including newer high strength ceramic materials) to a tooth substrate. Interface™ when used in conjunction with a resin adhesive can be used for ceramic and ceramic to tooth repairs, as well as bonding ceramic inlays, onlays, crowns and veneers.
Interface ™ is to be used as a ceramic primer/ conditioner allowing bonding to ceramic, dentin and enamel all at the same time. With Interface™, any dental ceramic can be repaired safely in the mouth without the use of dangerous hydrofluoric acid.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Interface™ is a ceramic primer which allows the clinician to bond any type of ceramic to a tooth substrate without the pre-application of hydrofluoric acid. Interface™ is prepared by mixing one drop of each component and then waiting 30 seconds for the materials to co-mix. The advantage of being able to mix these chemistries just prior to use, assures the clinician that the mixture is always fresh. Since both chemistries are separate prior to mixing the shelf life of the materials is very stable. In comparison, traditional hydrolyzed silane has an extremely short shelf life which can unknowingly jeopardize bond strengths once near expiration or expired.
Interface™ can be used to prime/ condition tooth structure prior to repairing a tooth to ceramic restoration. The need to acid etch the substrates prior to bonding with either phosphoric or hydrofluoric acids is not necessary. As a result this eliminates any confusion for the clinician on how to prep the restoration for successful bonding.
Interface™ can be used to bond to ceramic, dentin and enamel all at the same time.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tooth substrate, ceramic, dentin, enamel
Indicated Patient Age Range
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Intended User / Care Setting
Clinician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
510K Abbreviated Submission for Interface™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL. 60010
SH 10 of 14
ABBREVIATED 510 (K) SUMMARY
As Required by the Safe Medical Devices Act of 1990
Apex Dental Materials, Inc. 23329 Mallard Court Deer Park, IL. 60010 Tele- (877) 273-9123
510 (K) Submission Date: November 3, 2005
Contact Person: Chris Kulton
| Device Name: | |
|---|---|
| Trade Name: | Interface™ |
| Common Name: | Dental Bonding Adhesive |
| Classification Name: | Resin Tooth Bonding Agent, per 21 CFR parts 872.3200 |
| Classification: | |
| Regulatory Class: | II |
| Product Code: | KLE |
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE PREDICATE DEVICE
Raw silane (3-(Trimethoxysily)propyl methacrylate, 98%) hydrolyzed with acetic acid is an industry standard priming agent that is applied to prime ceramic surfaces pre-etched with hydrofluoric acid. This system combination is used to prepare inorganic ceramic surfaces prior to bonding with an organic resin based adhesive or cement. Historically hydrolyzed silane has been used to increase bonding strength, by acting as a coupling agent between the inorganic ceramic surface and the organic resin based restorative material. This basic coupling agent chemistry is only used to prime ceramics prior to bonding with an adhesive or cement. When
1
510K Abbreviated Submission for Interface™ Apex Dental Materials, 23329 Mallard Court Decr Park, IL. 60010
Continued:
repairing ceramic restorations involving tooth structure, this system does not have the capability to prime or condition exposed tooth substrate. This must be performed in a separate application protocol involving tooth etching conditioners such as a phosphoric acid gel.
DESCRIPTION OF APPLICATION DEVICE
Interface™ is a ceramic primer which allows the clinician to bond any type of ceramic to a tooth substrate without the pre-application of hydrofluoric acid. Interface™ is prepared by mixing one drop of each component and then waiting 30 seconds for the materials to co-mix. The advantage of being able to mix these chemistries just prior to use, assures the clinician that the mixture is always fresh. Since both chemistries are separate prior to mixing the shelf life of the materials is very stable. In comparison, traditional hydrolyzed silane has an extremely short shelf life which can unknowingly jeopardize bond strengths once near expiration or expired.
Interface™ can be used to prime/ condition tooth structure prior to repairing a tooth to ceramic restoration. The need to acid etch the substrates prior to bonding with either phosphoric or hydrofluoric acids is not necessary. As a result this eliminates any confusion for the clinician on how to prep the restoration for successful bonding.
Interface™ can be used to bond to ceramic, dentin and enamel all at the same time.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 FEB I
Mr. Chris Kulton Co-Owner Apex Dental Materials, Incorporated 23329 Mallard Court Deer Park, Illinois 60010
Re: K053103 Trade/Device Name: Interface™ Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 05, 2005 Received: January 11, 2006
Dear Mr. Kulton:
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. Iabeling, 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.
3
Page 2 – Mr. Chris Kulton
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" (21 CFR 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 yours,
Chris S. Liem, Ph.D.
Chiu S. Lin, PhD 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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SH 4 of 14
510K Abbreviated Submission for Interface™ Apex Dental Materials, 23329 Mallard Court Decr Park, IL. 60010
Indications for Use 11 053103
510(K) Number (if known):
Device name: Interface™
Indications For Use:
Interface "" is a ceramic primer/ conditioner, which allows the clinician to bond any type of ceramic (including newer high strength ceramic materials) to a tooth substrate. Interface "M when used in conjunction with a resin adhesive can be used for ceramic and ceramic to tooth repairs, as well as bonding ceramic inlays, onlays, crowns and veneers.
Interface ™ is to be used as a ceramic primer/ conditioner allowing bonding to ceramic, dentin and enamel all at the same time. With Interface "1", any dental ceramic can be repaired safely in the mouth without the use of dangerous hydrofluoric acid.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)
Prescription use X (Per 21 CFR 801.109
OR
Suver Runne
Over- The- Counter Use
(Optional Format 1-2-96)