(62 days)
SIMPLICITY™ (1), SIMPLICITY™ 2
No
The document describes a chemical dental adhesive system and its physical properties, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a dental adhesive system used for bonding and sealing, which are restorative dentistry procedures. While it can also be used to treat hypersensitive and/or exposed root surfaces, its primary function as described in both the 'Intended Use' and 'Device Description' sections is as an adhesive system for dental restorations.
No
Explanation: The device is described as a dental adhesive system used for bonding and sealing, not for diagnosing conditions.
No
The device description clearly indicates that SIMPLICITY™ is a light-cured, self-etching dental adhesive system, which is a physical material (a chemical substance) and not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dental adhesive system used for bonding to enamel and dentin, sealing preparations, bonding posts and cores, and treating hypersensitivity. These are all procedures performed directly on the patient's teeth and surrounding structures.
- Device Description: The description details a light-cured, self-etching dental adhesive system. This is a material applied to the tooth structure.
- Lack of In Vitro Testing: The text describes performance studies based on "shear bond strength to dentin and enamel," which are physical properties of the adhesive's interaction with tooth structure, not diagnostic tests performed on biological samples outside the body.
- No Mention of Biological Samples: There is no mention of the device being used to test or analyze biological samples such as blood, urine, tissue, etc., which is a key characteristic of IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic and restorative material used directly on the patient.
N/A
Intended Use / Indications for Use
SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.
SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light cured, self cured or dual cured composite cement or glass ionomer or resin-modified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.
Product codes
KLE
Device Description
SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.
SIMPLICITY™ 2 is an acetone based adhesive that is dependent on the prepared surface of its conditioner (SIMPLICITY™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER system. Applying the SIMPLICITY™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel/dentin, root surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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)
SIMPLICITY™ has similar handling to the ECLIPTOMER (Bisco, Inc.) adhesive system. From the physical testing observations and analysis, including shear bond strength to dentin and enamel, we suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER (Bisco, Inc.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
APR 2 4 2002
510K Submission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194
510 (K) SUMMARY
As Required by the Safe Medical Devices Act of 1990
Apex Dental Materials, Inc. 603 Berkley Court Schaumburg, IL, 60194 Phone: (847) 490-1014
510 (K) Submission Date: February 20, 2002
Contact Person: Chris Kulton
Device Name: SIMPLICITY™ Trade Name: 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
ECLIPTOMER (Bisco, Inc.) is a universal dental adhesive system that is designed to bond composite to dentin, enamel, cast metals, treated porcelain and set amalgam. This system is also designed for indirect techniques as well as amalgam bonding.
ECLIPTOMER (Bisco, Inc.) is an acetone based primer that is dependent on a clean etched dentin/enamel surface that is visibly moist. Its physical properties are similar to the applicant device and uses are identical. Like the applicant device, ECLIPTOMER is one component used in conjunction with a complete dental bonding system. It hardens by a light cure polymerization mechanism employing a light initiator, and a chemical activator.
SH 12 of 15
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510K Submission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194
Summary continued:
DESCRIPTION OF APPLICATION DEVICE
SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.
SIMPLICITY™ 2 is an acetone based adhesive that is dependent on the prepared surface of its conditioner (SIMPLICITY™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER system. Applying the SIMPLICITY™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol.
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510K Submission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194
Summary continued:
INTENDED USES OF APPLICANT DEVICE
SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light cured, self cured or dual cured composite cement or glass ionomer or resin-modified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.
PERFORMANCE CHARACTERISTICS and CONCEPTS
SIMPLICITY™ has similar handling to the ECLIPTOMER (Bisco, Inc.) adhesive system. From the physical testing observations and analysis, including shear bond strength to dentin and enamel, we suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER (Bisco, Inc.). Along with this we would suggest the individual components of SIMPLICITY™ are long time industry standards and are utilized in numerous dental bonding systems currently marketed in the United States (see Confidential Formulation Details on page 5).
Equivalent Product and Manufacturer
Corresponding 510(k) Numbers
ECLIPTOMER (Bisco, Inc.)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/13 description: The image shows a partial view of a logo or emblem. The visible portion includes the stylized depiction of an eagle or similar bird-like figure with outstretched wings, rendered in a thick, black line. To the left of the bird figure, there is text arranged vertically, which appears to be part of the phrase "DEPARTMENT OF HEALTH & HUMAN". The text is also in black and is oriented to be read from bottom to top.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2002
Mr. Chris Kulton Apex Dental Materials, Incorporated 603 Berkley Court Schaumburg, Illinois 60194
Re: K020570
Trade/Device Name: SIMPLICITYTM Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 20, 2002 Received: February 21, 2002
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, 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.
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.
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Page 2 - Mr. Chris Kulton
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Ulatowski Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510K Sybmission for SIMPLICITY™ Apex Dental Materials, 603 Berkley Court Schaumburg, IL. 60194
Indications for Use
510(K) Number (if known):
Device name: SIMPLICITY™
Indications For Use:
SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.
SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light cured, self cured or dual cured composite cement or glass ionomer or resin-modified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.
(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
Over- The- Counter Use
(Optional Format 1-2-96)
Susan Renner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices NOW IS 510(k) Number_