PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)

K100752 · Ultradent Products, Inc. · KLE · Jul 16, 2010 · Dental

Device Facts

• Record ID: K100752
• Device Name: PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
• Applicant: Ultradent Products, Inc.
• Product Code: KLE · Dental
• Decision Date: Jul 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak™ Universal Bond bonds to the following materials: Dentin and enamel Porcelain Metal Composite

Device Story

Peak™ Universal Bond is a single-syringe resin bonding agent used in restorative dentistry. It is 7.5% filled with an ethyl alcohol solvent carrier and contains 0.2% Chlorhexidine Diacetate to enhance long-term bond strength. The device is applied by a dental professional in a clinical setting to bond restorative materials (porcelain, metal, composite) to tooth structure (dentin, enamel). It is compatible with both total-etch and self-etch (Peak™ SE) techniques and is cured using high-intensity lights, including LEDs. The clinician applies the resin to the prepared tooth surface to facilitate adhesion of restorative materials. The addition of chlorhexidine aims to improve bond durability, potentially reducing the need for restorative replacement and benefiting the patient through longer-lasting dental repairs.

Clinical Evidence

Bench testing only. Comparative shear bond strength testing was performed on Peak™ Universal Bond, Peak™ Bond, and NexTemp using both Total Etch and Self Etch systems. Testing included thermal cycling to simulate clinical conditions. Results indicated that Peak™ Universal Bond exhibited higher shear bond strengths than the predicate Peak™ Bond.

Technological Characteristics

Single-syringe resin bonding agent; 7.5% filled with ethyl alcohol solvent carrier; contains 0.2% Chlorhexidine Diacetate. Cures via high-intensity light (including LEDs). Compatible with total-etch and self-etch systems. Shelf life validated to 18 months via accelerated stability testing (36°C elevation).

Indications for Use

Indicated for etching and bonding needs in restorative dentistry for patients of all ages, including bonding to dentin, enamel, porcelain, metal, and composite.

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

• Peak™ Bond (K063557)
• Premier NexTemp (K051866)

Submission Summary (Full Text)

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JUL 1 3 2010

KCO0752

# TRADITIONAL 510(K) PREMARKET SUMMARY

## Peak™ Universal Bond

This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for Peak™ Universal Bond.

#### Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

Contact Person: Title: Telephone: FAX: Date Summary Prepared: Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 March 3, 2010

### Name of the Device

Trade Name: Common Name: Device Classification: Classification Product Code: Peak™ Universal Bond Agent, Tooth bonding, Resin ll KLE

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## Legally Marketed Predicate Device to Which Equivalence is Claimed

The first predicate device is: Peak™ Bond (KO63557). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. Peak Bond and Peak Universal Bond are exactly the same product with only the addition of 0.2 Chlorhexidine Diacetate. The second predicate device is Premier NexTemp (K051866) manufactured and distributed by Premier Dental Products, 1710 Romano Drive, Plymouth meeting, PA 19462.

Product Description: Peak™ Universal Bond is a single syringe delivered resin bond. It can be used with Peak™ SE or with a total etch. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Chlorhexidine is used to ensure long term bond strengths.

Indications for Use: Use for virtually all etching and bonding needs in restorative dentistry for dental patients of all ages.

Peak™ Universal Bond bonds to the following materials:

- Dentin and enamel .
- � Porcelain
- Metal ♥
- Composite .

Traditional 510(k) for Peak™ Universal Bond

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# Comparison Table Table

| | Peak™ Universal Bond<br>(K100752) | Peak™ Bond<br>(K063557) | Premier NexTemp<br>(K051866) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>For Use | Use for virtually all etching and<br>bonding needs in restorative<br>dentistry.<br><br>Peak™ Universal Bond bonds<br>to the following materials:<br>Dentin and enamel Porcelain Metal Composite | Use for virtually all<br>etching and bonding<br>needs in restorative<br>dentistry.<br><br>Peak™ Bond bonds<br>to the following<br>materials:<br>Dentin and enamel Porcelain Metal Composite | Non-eugenol<br>resin-matrix<br>formulation<br>to combine<br>the multiple<br>benefits of<br>fluoride<br>release to<br>protect tooth<br>structure,<br>potassium<br>nitrate for<br>patient<br>comfort and<br>chlorhexidine<br>as an anti-<br>bacterial<br>agent. |
| Delivery<br>System | Syringe | Syringe | Syringe |

#### Technological Characteristics:

Peak™ Universal Bond is a single syringe delivered resin bond. It can be used with Peak™ SE or with a total etch. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Chlorhexidine is used to ensure long term bond strengths. Both devices have the same technological characteristics before the addition of chlorhexidine. New characteristics are added to enhance the length of the bond strength in Peak Universal Bond.

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The purpose of this Traditional 510(k) is to inform the FDA of our intent to market a new product, Peak™ Universal Bond. This product can be used for dental patients of all ages. Peak™ Bond (K063557) and Premier NexTemp (K051866) are our predicates. The formula has been modified as follows:

- Add 0.2 Chlorhexidine Diacetate �
Our goal is to release Peak™ Universal Bond as a new product potentially replacing Peak™ Bond.

The Indications for Use remains the same as Peak™ Bond. New labeling and packaging have been added to reflect Peak™ Universal Bond as a new product which is an improvement over Peak™ Bond with the addition of chlorhexidine which was added to ensure long term bond strengths.

Peak Universal Bond is a dental composite material used for virtually all etching and bonding needs in restorative dentistry.

## Brief Description of Testing Performed

We repeated the exact same testing as was performed on Peak™Bond (K063557). The bond strength that was tested on Peak™LC compared to Peak™ Universal bond and NexTemp using a Total Etch system and a Self Etch System. Then, all three products were thermal cycled and all parameters were again tested. The test data is included in Section IV. The test data shows that Peak™ Universal Bond has higher shear bond strengths than Peak™ Bond, which was superior to its predicates when tested in (K063557) and NexTemp.

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## Stability Testing for Shelf Life

Stability testing was also conducted on Peak Universal Bond and the results showed that the product has an 18 month shelf life based on accelerated stability studies conducted in R & D. The timing of seven weeks of storage at a temperature elevated 36°C above ambient is equivalent to 84.9 weeks or 19.5 months of real time shelf life.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing the branches of government.

#### Public Health Service

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

## JUL 1 32010

Ms. Diane Rogers Regulatory Affairs Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

Re: K100752

Trade/Device Name: Peak™ Universal Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 24, 2010 Received: June 25, 2010

#### Dear Ms. Rogers:

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. Rogers

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Statement of Indications for Use

510(k) Number (if known):

Device Name: _ Peak™ Universal Bond

### Indications for Use:

Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages.

Peak™ Universal Bond bonds to the following materials:

- Dentin and enamel �
- Porcelain
- Metal .
- Composite

AND/OR Over-The-Counter Use Prescription Use _ X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

C l Hee
Page 1 of 1

(Posted November 13, 2003)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100752

Traditional 510(k) for Peak™ Universal Bond