AQUASIL XLV SMART WETTING IMPRESSION MATERIAL

K973782 · Dentsply Intl. · ELW · Dec 4, 1997 · Dental

Device Facts

• Record ID: K973782
• Device Name: AQUASIL XLV SMART WETTING IMPRESSION MATERIAL
• Applicant: Dentsply Intl.
• Product Code: ELW · Dental
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is a twopart (base/catalyst) hydrophilic viny|polysiloxane (VPS), impression material used to record the details of hard and soft surfaces of the oral cavity. Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Regular Set is used for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material. Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

Device Story

Aquasil XLV Smart Wetting Impression Material is a two-part (base/catalyst) hydrophilic vinylpolysiloxane (VPS) elastomeric material. It functions as a dental impression medium to record details of hard and soft oral tissues. The material is supplied in cartridge delivery systems. Clinicians use the material in dental offices for dual-phase impression techniques or model duplication. The Regular Set is designed for multiple-unit impressions, while the Fast Set is optimized for single-unit crown preparations. The device improves wetting of tooth surfaces and model detail reproduction compared to traditional materials. It is a prescription-only device used by dental professionals.

Clinical Evidence

No clinical data. Safety is supported by bench testing of the predicate device (K943574), including cytotoxicity, dermal toxicity, irritation, and Ames mutagenicity testing. The material is non-mutagenic, non-toxic, and a non-irritant with limited intraoral exposure time (less than ten minutes).

Technological Characteristics

Hydrophilic vinylpolysiloxane (VPS) elastomeric impression material. Two-part base/catalyst system. Supplied in cartridge delivery. Formulated with adjusted catalyst and retarder concentrations for specific setting speeds (Regular/Fast). Biocompatible materials consistent with previously marketed DENTSPLY devices.

Indications for Use

Indicated for use as an impression material for recording hard and soft oral cavity surfaces, including dual phase techniques and model duplication. Regular Set is indicated for multiple unit impressions; Fast Set is indicated for single unit crown preparations and double arch dual phase techniques.

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™ Smart Wetting Impression Material (K943574)

Submission Summary (Full Text)

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510(k) SUMMARY DEC - 4 1997 Page 1 of 2

Image /page/0/Picture/17 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word appears to be a logo or brand name.

NAME & ADDRESS:

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 [phone] ax 1777 054-2343

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn DATE PREPARED: October 2, 1997

AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL TRADE NAME:

CLASSIFICATION NAME: Impression Material

PREDICATE DEVICE: Aquasil™ Smart Wetting Impression Material K943574

DEVICE DESCRIPTION: AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is an extra low viscosity. elastomeric impression material with excellent hydrophilic properties, dimensional accuracy. high tear strength, and resistance to permanent deformation. AQUASIL XLV IMPRESSION MATERIAL with "smart wetting" improves wetting both the tooth surface and the model detail reproduction.

AQUASIL XLV SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. It is available in cartridge delivery. In developing the Regular Set and Fast Set, adjustments were made to the active ingredients as compared to the predicate device (K943574). These adjustments were made to obtain two speeds of the material with improved physical properties. The speed of the materials was adjusted by increasing the amounts of catalyst and retarder fluids over the predicate device. These changes improved the setting properties of the mixed impression material and allowed for two speeds of the same viscosity of impression material. Other changes were made to improve the flow property of the mixed impression material and the shelf stability of the product.

INTENDED USE: AQUASIL™ XLV SMART WETTING IMPRESSION MATERIAL is a twopart (base/catalyst) hydrophilic viny|polysiloxane (VPS), impression material used to record the details of hard and soft surfaces of the oral cavity.

Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models.

Regular Set is used for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material.

Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

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## TRADE NAME: AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL

TECHNOLOGICAL CHARACTERISTICS: All of the components of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL have been used in DENTSPLY legally marketed devices.

Due to the similarity of the formulation of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL to the predicate device (K943574), we believe that additional biocompatibility testing of the new impression material is unnecessary.

The predicate device. Aquasil Smart Wetting Impression Material, was evaluated and the reports can be found in K943574:

The catalyst and base pastes and the mixed product were evaluated for cytoxicity. The mixed product was evaluated for dermal toxicity, for initation, and for mutagenicity.

The base pastes give a moderate cytotoxicity and the catalyst pastes were noncytotoxic. When mixed, the cytotoxicity persisted, but was recorded as a lower value than the value for Reprosil® Impression Material.

The mixed product was tested by the Ames Mutagenicity Test. Acute Dermal Toxicity Test, and the Hamster Cheek Pouch Imitation Study. The final product is non-mutagenic, non-toxic, and a non-irritant.

As impression materials, AQUASIL XLV SMART WETTING IMPRESSION MATERIAL and the predicate device (K943574) are in the mouth for less than ten minutes.

We believe that the prior use of the components in DENTSPLY legally marketed devices, the similarity of formulation to the predicate device, the final product testing of the predicate device, the limited exposure time in the mouth, and the performance data outlined above support the safety and effectiveness of AQUASIL XLV SMART WETTING IMPRESSION MATERIAL for the intended uses.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**DEC - 4 1997**

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

K973782 Re : Aquasil XLV Smart Wetting Impression Trade Name: Material II Requlatory Class: Product Code: ELW October 2, 1997 Dated: Received: October 3, 1997

Dear Mr. Lehn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Lehn

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic childuli 312 or on notrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

| 510(K) Number: | K973782 |
|----------------|---------|
|----------------|---------|

Device Name: AQUASIL™ XLV SMART WETTING® IMPRESSION MATERIAL

Indications for Use:

Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models.

Regular Set is used for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material.

Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✔

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Snover

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

000007