AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL

K021410 · Dentsply Intl. · ELW · May 8, 2002 · Dental

Device Facts

• Record ID: K021410
• Device Name: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
• Applicant: Dentsply Intl.
• Product Code: ELW · Dental
• Decision Date: May 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

AQUASIL ULTRA 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. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

Device Story

Hydrophilic vinylpolysiloxane impression material; two-part catalyst/base formulation. Supplied in 1:1 ratio cartridges. Used by dental professionals in clinical settings for capturing dental impressions and model duplication. Material exhibits extra low viscosity; available in regular and fast set variants. Applied by clinician to patient's oral cavity to record dental anatomy; output is a physical impression used for restorative dentistry. Benefits include precise anatomical replication for dental prosthetics.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on both uncured and cured material, including cytotoxicity, mutagenicity, irritation, and sensitization assays. All tests passed.

Technological Characteristics

Hydrophilic vinylpolysiloxane impression material; two-part catalyst/base system; extra low viscosity; 1:1 cartridge delivery system. Biocompatible per cytotoxicity, mutagenicity, irritation, and sensitization testing.

Indications for Use

Indicated for dental impression procedures, including dual phase techniques and model duplication. Regular Set is for multiple unit impressions; Fast Set is for single unit crown preparations and double arch dual phase techniques. Suitable for any clinical scenario requiring extra low viscosity impression material.

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 XLV™ Smart Wetting Impression Material (K973782)

Submission Summary (Full Text)

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## 510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

K021410

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171845-7511 P. J. Lehn Telefax (7 7) 849-4343

P. Jeffery Lehn CONTACT:

May 2, 2002 DATE PREPARED:

TRADE NAME: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL

Impression Material (872.3660) CLASSIFICATION NAME:

PREDICATE DEVICES: Aquasil XLV™ Smart Wetting Impression Material K973782

DEVICE DESCRIPTION: MATERIAL is a two-part catalyst/base hydrophilic vinylpolysiloxane impression material. It is formulated for regular set and fast set. This impression material is an extra low viscosity and is available in (1:1 ratio) cartridges.

AQUASIL ULTRA XLV SMART WETTING IMPRESSION INTENDED USE: MATERIAL is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

TECHNOLOGICAL CHARACTERISTICS: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL represents a modification to Aquasil XLV Smart Wetting Impression Material (K943754).

All of the components have been used in legally marketed devices or were found to be safe for use. Uncured AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL was evaluated and passed biocompatibility testing for cytotoxicity. Cured AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL was evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, irritation and sensitization.

We believe that the data provided regarding the modifications to the predicate device support the safety and effectiveness of AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL for the indicated uses.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 0 8 2002

Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405

Re: K021410

Trade/Device Name: Aquasil Ultra XLV Smart Wetting Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 02, 2002 Received: May 03, 2002

Dear Mr. Lehn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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.

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#### Page 2 -- Mr. P. Jeffery Lehn

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Patrice Cucent/fx

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

Enclosure

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### INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known):

102 1410

# Device Name: AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL

Indications for Use:

Used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

These are the same Indications for Use as previously cleared for the Aquasil XL VTM Smart Wetting Impression Material (K973782).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Runnes

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

(Per 21 CFR 801.109)

MODIFICATION TO K973782