Direct-placed light-curing composite and compomer restorations.
Direct-placed core build-ups with light-, self- and dual-curing composites.
Repair of fractured composite and compomer restorations.
– Adhesive cementation of indirect restorations with light- and dual-curing luting composites.
Sealing of prepared tooth surfaces before temporary / permanent cementation of indirect restorations.
Desensitization of hypersensitive cervical areas.

Device Description

Adhese® Universal is a light-curing single-component dental adhesive for enamel and dentin.

AI/ML Overview

The provided text describes the 510(k) summary for the Adhese® Universal dental adhesive. It details its comparison to a predicate device, its intended use, technological characteristics, and testing summary. However, it does not provide detailed acceptance criteria and a study report with the level of detail requested in the prompt, especially for AI/ML device testing.

Here's an analysis based on the information available, and highlighting what is missing in the context of an AI/ML device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device (3M Adhesive EXL 759 (K110302))	"The comparison shows that Adhese Universal is substantially equivalent to the predicate device."
Shear bond strength to dentin and enamel	"the results from testing demonstrate that Adhese Universal is substantially equivalent to the predicate device."
Biocompatibility	"Biocompatibility testing and evaluation was also carried out according to ISO 10993." (Implied acceptance, no specific result given beyond completion of test)

Missing Information (Crucial for AI/ML devices): Specific quantitative thresholds for "substantial equivalence" regarding shear bond strength or other performance metrics. The document only states that it was found to be substantially equivalent without detailing how that was determined or the specific numerical results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated. The document mentions "standard shear bond strength method (see ISO 29022 for sample preparation)" but does not specify the number of samples tested for Adhese Universal or the predicate device.
Data Provenance: Not specified.

Missing Information (Crucial for AI/ML devices): The number of individual teeth or samples tested for bond strength, and their origin (e.g., human cadaveric teeth, bovine teeth, specific age groups, etc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this device. Adhese® Universal is a dental adhesive, not an AI/ML diagnostic or predictive device that relies on expert interpretation for ground truth. Its performance is measured through physical/mechanical properties like shear bond strength and biocompatibility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable to this device, as it's not an AI/ML device requiring expert adjudication of results. The testing method appears to be laboratory-based physical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable to this device, as it's not an AI/ML device involving human readers or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable to this device, as it is a physical dental adhesive, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be the direct measurements from laboratory tests:

Shear bond strength: Measured values (e.g., in MPa) obtained from mechanical testing according to ISO 29022.
Biocompatibility: Results from tests performed according to ISO 10993 (e.g., cytotoxicity, sensitization, irritation indices).

8. The sample size for the training set

This section is not applicable as this is not an AI/ML device and therefore does not have a training set. The "development" would involve chemical formulation and iterative testing, not machine learning model training.

9. How the ground truth for the training set was established

This section is not applicable as this is not an AI/ML device and therefore does not have a training set.

Summary for the provided device in terms of AI/ML criteria:

The provided document describes a dental adhesive (Adhese® Universal), which is a physical material, not an AI/ML device. Therefore, most of the questions related to AI/ML specific testing (such as ground truth establishment by experts, adjudication methods, MRMC studies, training sets, etc.) are not applicable.

The study described (testing for shear bond strength and biocompatibility) is a laboratory-based study comparing the new device against a predicate device to establish substantial equivalence based on physical and biological properties, not cognitive performance. The acceptance criteria are implicitly that the device performs equivalently to the predicate device in these tests. The specific numerical data from these tests is not provided in this summary.

Summary

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510(K) SUMMARY

Adhese® Universal

Image /page/0/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" written below. Above the company name is a series of dots arranged in an arc. At the top of the image is the text "K 133316".

Contact:	Donna Marie Hartnett
Company:	Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535
Date Prepared:	November 8, 2013
Proprietary Name:	Adhese® Universal
Classification Name:	Dental Adhesive (872.3200) (Classification Code KLE))
Predicate Devices:	3M Adhesive EXL 759 (K110302) (Scotchbond Universal))
Device Description:	Adhese® Universal is a light-curing single-component dental adhesive for enamel and dentin.

FEB 1 1 2014The predicate device to which Adhese Universal cement has been compared is Scotchbond Universal (3M Adhesive EXL 759 (K110302). For this application, Adhese Universal has been compared to its predicate with regard to chemical composition, performance data and indications for use. The comparison shows that Adhese Universal is substantially equivalent to the predicate device.

Intended Use: - Direct-placed light-curing composite and compomer restorations.

Direct-placed core build-ups with light-, self- and dual-curing composites.
Repair of fractured composite and compomer restorations.
Adhesive cementation of indirect restorations with light- and dual-curing luting composites.

– Sealing of prepared tooth surfaces before temporary / permanent cementation of indirect restorations.

Desensitization of hypersensitive cervical areas.
Technological Characteristics: The device design, i.e. delivery form, and intended use of Adhese Universal and the predicate device are the same except Adhese Universal is also marketed in a Vivapen delivery form. The Vivapen is a state of the art applicator for dental adhesives, which is successfully in use with other IVAG dental adhesives (e.g. AdheSE One F, ExciTE F). The composition of the subject device has been modified from the predicate.

Testing Summary: The device was tested for shear bond strength to dentin and enamel using the standard shear bond strength method (see ISO 29022 for sample preparation) and the results from testing demonstrate that Adhese Universal is substantially equivalent to the predicate device. Biocompatibility testing and evaluation was also carried out according to ISO 10993.

CONCLUSION: The above data and analysis demonstrates that Adhese® Universal is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 11, 2014

Ivoclar Vivadent, Incorporated Donna Marie Hartnett, Esq. Director QA/Regulatory Affairs 175 Pineview Drive Amherst, New York 14228

Re: K133318

Trade/Device Name: Adhese Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Codes: KLE, LBH Dated: November 8, 2013 Received: November 14, 2013

Dear Ms. Hartnett:

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. 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.

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Page 2 -Ms. Hartnett

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Image /page/2/Picture/5 description: The image shows the text "Kwame O. Ulmer -S FDA". The text is in a simple, sans-serif font. The letters are black and the background is white. The text is slightly distorted, as if it were printed on a slightly uneven surface.

for

Erin I. Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Adhese® Universal

Indications For Use:

Direct-placed light-curing composite and compomer restorations.
Direct-placed core build-ups with light-, self- and dual-curing composites.
Repair of fractured composite and compomer restorations.

– Adhesive cementation of indirect restorations with light- and dual-curing luting composites.

Sealing of prepared tooth surfaces before temporary / permanent cementation of indirect restorations.
Desensitization of hypersensitive cervical areas.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Mary S. Runner
2014.01.27
07:55:16.05'00'
Susan Runner

Regulation Number and Section

§ 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.