ADHESE UNIVERSAL

K133318 · Ivoclar Vivadent, AG · KLE · Feb 11, 2014 · Dental

Device Facts

• Record ID: K133318
• Device Name: ADHESE UNIVERSAL
• Applicant: Ivoclar Vivadent, AG
• Product Code: KLE · Dental
• Decision Date: Feb 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

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.

Device Story

Adhese Universal is a light-curing, single-component dental adhesive used for bonding enamel and dentin. It is applied by dental professionals in a clinical setting. The device is supplied in a bottle or a Vivapen delivery system, which is an applicator for precise placement. The adhesive is used to bond restorative materials (composites, compomers, luting cements) to tooth structure or to treat hypersensitive cervical areas. By providing a chemical bond between the tooth and the restorative material, it improves the retention and marginal integrity of dental restorations, thereby benefiting the patient by restoring tooth function and aesthetics.

Clinical Evidence

Bench testing only. Shear bond strength to dentin and enamel was evaluated using ISO 29022 methodology. Biocompatibility was assessed according to ISO 10993 standards. No clinical data was provided.

Technological Characteristics

Light-curing, single-component dental adhesive. Delivery via bottle or Vivapen applicator. Biocompatibility tested per ISO 10993. Shear bond strength testing performed per ISO 29022.

Indications for Use

Indicated for patients requiring dental restorative procedures, including direct composite/compomer restorations, core build-ups, repair of fractured restorations, adhesive cementation of indirect restorations, sealing of prepared tooth surfaces, and desensitization of hypersensitive cervical areas.

Regulatory Classification

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.

Predicate Devices

• 3M Adhesive EXL 759 (Scotchbond Universal) (K110302)

Reference Devices

• AdheSE One F
• ExciTE F

Submission Summary (Full Text)

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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, AG<br>Bendererstrasse 2, Schaan, FL-9494, Liechtenstein<br>[phone] |
| 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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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 [phone] or [phone] 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 [phone] or [phone] 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