AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL

K113406 · Dentsply International, Inc. · ELW · Feb 13, 2012 · Dental

Device Facts

• Record ID: K113406
• Device Name: AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
• Applicant: Dentsply International, Inc.
• Product Code: ELW · Dental
• Decision Date: Feb 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is indicated for all dental impression techniques.

Device Story

Aquasil Ultra Smart Wetting Impression Material is a two-part hydrophilic vinylpolysiloxane elastomeric material used by dental professionals to create dental impressions. Available in light, medium, and heavy-bodied consistencies with varying set times (fast, regular, extended). The material is applied by the clinician to capture the anatomy of the oral cavity. It serves as a physical mold for dental restorations or diagnostic models. The device is used in a clinical dental setting. It is contraindicated for use as a temporary reliner and should not be used with polyether, polysulfide, or condensation silicone materials.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical performance data, including toxicological assessment and physical property testing, confirming that minor quantitative ingredient changes do not alter the material's performance compared to the predicate devices.

Technological Characteristics

Hydrophilic vinylpolysiloxane elastomeric impression material. Two-part catalyst/base system. Available in light, medium, and heavy-bodied consistencies. No changes to fundamental technology or chemical composition from predicates. Minor quantitative ingredient adjustments.

Indications for Use

Indicated for all dental impression techniques. Contraindicated for patients with a history of severe allergic reaction to peppermint oil or any of the components.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Aquasil Ultra XLV Smart Wetting Impression Material (K021410)
• Aquasil Ultra Rigid Smart Wetting Impression Material (K021413)
• Aquasil Ultra Monophase, Heavy and LV Smart Wetting Impression Material (K021416)

Submission Summary (Full Text)

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K113406

Suite 60W

DENTSPLY International World Headquarters

York, PA 17405-0872 18001 877-0020

Fax [phone] www.dentsply.com

Susquehanna Commerce Center 221 West Philadelphia Street

1.

## SECTION 5. 510(k) SUMMARY for Title of Submission

Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |

November 11, 2011 Date Prepared:

#### 2. Device Name:

- Proprietary Name: .
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL

Material, Impression 872.3660

- CFR Number: Device Class:
Classification Name:

- [] . ELW Product Code: .
#### Predicate Device: 3.

.

.

DENTSPLY International's:

- . K021410- Aquasil Ultra XLV Smart Wetting Impression Material .
- K021413- Aquasil Ultra Rigid Smart Wetting Impression Material .
- K021416- Aquasil Ultra Monophase, Heavy and LV Smart Wetting Impression . Material .

#### 4. Description of Device:

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is a two-part catalyst/base hydrophilic viny!polysiloxane elastomeric impression material suitable for all dental impression techniques where a light body (wash) and/or medium/heavy body (tray) material would be desired by the operator. Aquasil Ultra Smart Wetting Impression Material is available in light-bodied, medium-bodied or heavy-bodied consistencies; and fast set. regular set or extended work time.

- న్. Indications for Use:
Aquasil Ultra Smart Wetting Impression Material is indicated for all dental impression techniques.

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#### Description of Safety and Substantial Equivalence: 6.

### Technological Characteristics

There are no changes proposed in this premarket notification which affect the fundamental technological characteristics of the subject devices. The intent of this premarket notification is: 1). The addition of the contraindication. "Aquasil Ultra Impression Material is contraindicated for use with patients who have a history of severe allergic reaction to peppermint oil or any of the components": 2). Clarification of warnings and precautions through the addition of warning against the use of the devices as a temporary reliner as well as a precaution their use with polvether. polysulfide, or condensation silicone materials; 3). Consolidation of Indications for Use; and 4). Documentation of minor quantitative changes to the existing ingredients in the composition of the AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL. AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL, and AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL cleared in premarket notifications K021410, K021413, and K021416, respectively. The changes described do not affect the substantial equivalence of the devices as originally cleared in premarket notifications K021410, K021413, and K021416.

### Non-Clinical Performance Data.

#### Toxicological Testing

All of the components used in the subject impression materials have been used in the devices as cleared in premarket notifications K021413, and K021416. There are no changes to the material composition of the subject impression materials proposed in this premarket notification.

### Physical Properties

The purpose of this premarket notification is the addition of a contraindication; clarification of warnings and precautions; and clarification of the Indications for Use of the existing AOUASIL ULTRA SMART WETTING MATERIALS previously cleared in premarket notifications K021410, K021413, and K021416. There are no changes affecting the fundamental technology and chemical composition of the subject materials. There are minor quantitative changes to the existing ingredients in the material composition, but these changes do not affect the physical characteristics and mechanical properties of the materials.

Clinical Performance Data. Not applicable.

### Conclusion as to Substantial Equivalence

AQUASIL ULTRA XLV, LV, MONOPHASE, HEAVY, RIGID, XTRA WASH and XTRA TRAY SMART WETTING IMPRESSION MATERIAL are substantially equivalent to the currently marketed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

FEB 1 3 2012

Re: K113406

Trade/Device Names: Aquasil Ultra Smart Wetting Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 11, 2011 Received: November 18, 2011

Dear Ms. Lewis:

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 approval approvisions 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 If your device is chasilited (so itional 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. Lewis

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 (reporting of inements 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 1 ou may 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 vours.

Wh 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

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# SECTION 4. INDICATIONS FOR USE STATEMENT

113406

510(k) Number (if known):

Device Name: AQUASIL ULTRA SMART WETTNG IMPRESSION MATERIAL

Indications for Use:

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is indicated for all dental impression techniques.

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

Over-The-Counter Use (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)

Swen Rumpis

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

510(k) Number:

113406

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DENTSPLY International