AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL

K021416 · Dentsply Intl. · ELW · May 13, 2002 · Dental

Device Facts

• Record ID: K021416
• Device Name: AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
• Applicant: Dentsply Intl.
• Product Code: ELW · Dental
• Decision Date: May 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Used as impression materials in a dual phase impression technique. They 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 a monophase, heavy, or 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 materials; two-part catalyst/base formulation. Used by dental professionals to record hard and soft oral tissue details or duplicate models. Available in regular and fast set variants; monophase, heavy, and light (LV) viscosities. Delivered via 1:1 cartridges or 5:1 bulk delivery systems. Material applied to oral cavity to capture anatomical impressions; provides high-precision negative molds for dental restorations. Benefits include improved wetting properties for accurate detail reproduction.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Hydrophilic vinylpolysiloxane impression material. Two-part catalyst/base system. Viscosities: Monophase, Heavy, and Light (LV). Delivery: 1:1 cartridges or 5:1 bulk. Regular and Fast set formulations.

Indications for Use

Indicated for use as dental impression materials for capturing hard and soft oral tissue details and model duplication. Suitable for single unit crowns (Fast Set) and multiple unit impressions (Regular Set) using monophase, heavy, or low viscosity 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 Monophase & Heavy and LV™ S.W. Impression Materials (K946574)

Submission Summary (Full Text)

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## MAY 1 3 2002

## 510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

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

1021416

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT:

May 2, 2002 DATE PREPARED:

### TRADE NAME: AQUASIL ULTRA MONOPHASE SMART WETTING IMPRESSION MATERIAL AQUASIL ULTRA HEAVY SMART WETTING IMPRESSION MATERIAL AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIAL

CLASSIFICATION NAME:

Impression Material (872.3660)

PREDICATE DEVICE: Aquasil Monophase & Heavy and LV™ S.W. Impression Materials K946574

DEVICE DESCRIPTION: AQUASIL ULTRA MONOPHASE, AQUASIL ULTRA HEAVY, AND AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIALS are two-part catalyst/base hydrophilic vinylpolysiloxane impression materials used to record details of hard and soft tissues of the oral cavity. They are formulated for regular set and fast set. AQUASIL ULTRA MONOPHASE and AQUASIL ULTRA HEAVY SMART WETTING IMPRESSION MATERIALS are medium viscosity and available in (1:1 ratio) cartridges or (5:1 ratio) for bulk delivery. AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIAL is a light viscosity and is available in (1:1 ratio) cartridges.

AQUASIL ULTRA MONOPHASE, AQUASIL ULTRA HEAVY, AND INTENDED USE: AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIALS are used as impression materials in a dual phase impression technique. They 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 a monophase, heavy, or low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The seal is black and white.

# MAY 1 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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: K021416

Trade/Device Names: Aquasil Ultra Monophase Smart Wetting Impression Material Aquasil Ultra Heavy Smart Wetting Impression Material Aquasil Ultra LV 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.

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### Page 2 – Mr. P. Jeffery Lehn

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. or the ret of 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 nother 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,

Patreece Curciotti fta

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)

#### K021416 510(K) Number (if known):

#### Device Names:

### AQUASIL ULTRA MONOPHASE SMART WETTING IMPRESSION MATERIAL AQUASIL ULTRA HEAVY SMART WETTING IMPRESSION MATERIAL AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIAL

Indications for Use:

Used as impression materials in a dual phase impression technique. They may also be Used as impression macrials in a daal prises for capturing multiple unit used for precise duplication of models. Son techniques where the operator needs a mipressions. It 1s sumble 101 an material. Use Fast Set for capturing one preparation monophase, neary, orror, ideal for double arch dual phase techniques.

These are the same Indications for Use as previously cleared for the marketed devices (K943574).

# (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

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Susan Romero

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

SPECIAL 510(k)

MODIFICATION TO K943574