(18 days)
No
The device description and intended use focus on the chemical composition and application process of a dental adhesive system, with no mention of AI or ML capabilities.
No
The device is described as an adhesive system for dental restorations and to treat hypersensitive root surfaces, not as a therapeutic device.
No
The device is an adhesive system used for sealing and bonding dental materials, and for treating hypersensitive root surfaces. Its intended uses are therapeutic/restorative, not diagnostic.
No
The device description clearly describes a chemical adhesive system with multiple components (SURPASS™ 1, SURPASS™ 2, SURPASS™ 3) that are applied to dental surfaces and light-cured. This is a physical product, not software.
Based on the provided text, 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.
- SURPASS™ Function: The description of SURPASS™ clearly indicates it is a dental adhesive system used to bond materials to teeth (enamel/dentin) and treat hypersensitivity. It is applied directly to the patient's teeth and is part of a restorative or desensitization procedure.
- No Sample Analysis: There is no mention of SURPASS™ being used to analyze a sample taken from the body to provide diagnostic information.
Therefore, SURPASS™ is a dental device used for therapeutic and restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
- Indirect Restorations: 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.
- Desensitization: to treat hypersensitive and/or exposed root surfaces.
- To bond in a post and core.
Product codes
KLE
Device Description
SURPASS™ 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 sensitive. The bonding system combines both the etchant and primer applications into one simple step followed by a thin layer of unfilled bonding resin. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity.
SURPASS™ 2 is an ethanol-based adhesive that is dependent on the prepared surface of its conditioner (SURPASS™ 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 (510K number K945604, Bisco, Inc.) system. Applying the SURPASS™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol. Once SURPASS™ 2 has been dried a thin layer of SURPASS™ 3 is applied to the SURPASS™ 2 surface and light cured for 20 seconds. The SURPASS™ 3 acts as a superior tie layer between SURPASS™2 and the filling material of choice.
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)
SURPASS™ has similar handling to the ECLIPTOMER (510K number K945604, Bisco, Inc.) adhesive system. From the physical testing observations and analysis, including shear bond strength to dentin and enamel, we suggest that SURPASS™ is substantially equivalent to ECLIPTOMER (510K number K945604, Bisco, Inc.). Along with this we would suggest the individual components of SURPASS™ are long-time industry standards and are utilized in numerous dental bonding systems currently marketed in the United States. In addition, SURPASS™ is essentially our Simplicity® Adhesive System (510K: K020570) with an added bonding resin (SURPASS™ 3). SURPASS™ has the same indication for use and same base composition as the Simplicity® Adhesive System (510K: K020570).
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
§ 872.3200 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
107 4
KD6/981
JUL 3 1 2006
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 Phone: (877) 273-9123
July 12th, 2006 Abbreviated 510 (K) Submission Date:
II KLE
Chris Kulton Contact Person:
Device Name:
Trade Name: Common Name: Classification Name: SURPASS™ Dental Bonding Adhesive Resin Tooth Bonding Agent, per 21 CFR parts 872.3200
Classification:
| Regulatory Class: | |
|---|---|
| Product Code: |
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
PREDICATE DEVICE
ECLIPTOMER (510K number K945604, 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 (510K number K945604, 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 (510K number K945604, Bisco, Inc.) is one component used in conjunction with
Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010
Page 12 of 15
1
K06/981
2 of 4
a complete dental bonding system. It hardens by a light cure polymerization mechanism employing a photo initiator, and a chemical activator.
Summary continued:
DESCRIPTION OF APPLICATION DEVICE
SURPASS™ 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 sensitive. The bonding system combines both the etchant and primer applications into one simple step followed by a thin layer of unfilled bonding resin. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity.
SURPASS™ 2 is an ethanol-based adhesive that is dependent on the prepared surface of its conditioner (SURPASS™ 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 (510K number K945604, Bisco, Inc.) system. Applying the SURPASS™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol. Once SURPASS™ 2 has been dried a thin layer of SURPASS™ 3 is applied to the SURPASS™ 2 surface and light cured for 20 seconds. The SURPASS™ 3 acts as a superior tie layer between SURPASS™2 and the filling material of choice.
Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials. 23329 Mallard Court Deer Park, IL 60010
Page 13 of 15
2
K06/98/
3074
Summary continued:
INTENDED USES OF APPLICANT DEVICE
SURPASS™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light-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 resinmodified 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
SURPASS™ has similar handling to the ECLIPTOMER (510K number K945604, Bisco, Inc.) adhesive system. From the physical testing observations and analysis, including shear bond strength to dentin and enamel, we suggest that SURPASS™ is substantially equivalent to ECLIPTOMER (510K number K945604, Bisco, Inc.). Along with this we would suggest the individual components of SURPASS™ 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). In addition, SURPASS™ is essentially our Simplicity® Adhesive System (510K: K020570) with an added bonding resin (SURPASS™ 3). SURPASS™ has the same indication for use and same base composition as the Simplicity® Adhesive System
(510K: K020570).
Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010
Page 14 of 15
3
K06/98/
4084
Indications for Use
510(K) Number (if known):
SURPASSTM Device name:
Indications For Use:
- . Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
- Indirect Restorations: 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.
- . Desensitization: to treat hypersensitive and/or exposed root surfaces.
- To bond in a post and core .
(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)
Page 4 of 15
Abbrevaited 510K Submission for SURPASSTM Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
Mr. Chris Kulton Apex Dental Materials, Incorporated 23329 Mallard Court Deer Park, Illinois 60010
Re: K061981
Trade/Device Name: Surpass™M Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 12, 2006 Received: July 17, 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, 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.
5
Page 2 - Mr. 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" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(K) Number (if known):
SURPASS™ Device name:
Indications For Use:
- · Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials.
- Indirect Restorations: 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.
- Desensitization: to treat hypersensitive and/or exposed root surfaces. ◆
- To bond in a post and core .
(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
Apex Dental Materials,
23329 Mallard Court
Deer Park, IL 60010
Abbrevaited 510K Submission for SURPASSTM
OR
Over- The- Counter Use
(Optional Format 1-2-96)
Mubey for MSK Page 4 of 15
..un Sign-Off)
on of Anesthesiology, General Hospital.
cuon Control, Dental Devices
K06198)