AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL

K973781 · Dentsply Intl. · ELW · Dec 11, 1997 · Dental

Device Facts

• Record ID: K973781
• Device Name: AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL
• Applicant: Dentsply Intl.
• Product Code: ELW · Dental
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Indications for Use

AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.

Device Story

Aquasil Easy Mix Putty Impression Material is a high-viscosity, elastomeric dental impression material; consists of two-component base and catalyst pastes. Used by dental professionals as a tray material in dual-phase impression techniques to capture impressions of teeth and oral tissue. Material features 'smart wetting' properties to improve surface wetting and model detail reproduction. Hardens to form a base for final impressions. Benefits include dimensional accuracy, high tear strength, and resistance to permanent deformation. Limited intraoral exposure time (less than ten minutes).

Clinical Evidence

No clinical data. Evidence consists of bench testing including Ames Mutagenicity Test, Acute Dermal Toxicity Test, and Hamster Cheek Pouch Irritation Study. Biocompatibility data (cytotoxicity) was leveraged from predicate device K943574.

Technological Characteristics

Very high viscosity, elastomeric impression material. Two-component system (base and catalyst paste). Features 'smart wetting' technology. Material properties include dimensional accuracy, high tear strength, and resistance to permanent deformation.

Indications for Use

Indicated for use as a tray material in dual-phase impression techniques for taking multiple unit impressions of teeth and/or oral tissue.

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

• Reprosil® Putty Impression Material (K781151A)
• Aquasil Smart Wetting® Impression Material (K943574)

Submission Summary (Full Text)

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# 510(k) SUMMARY

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DENTSPLY

#### NAME & ADDRESS:

K973781

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

P. J. Lehn Telefax [phone]

| CONTACT: | P. Jeffery Lehn |
|----------------------|---------------------------------------------|
| DATE PREPARED: | September 19, 1997 |
| TRADE NAME: | AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL |
| CLASSIFICATION NAME: | Impression Material |

| PREDICATE DEVICE: | Reprosil® Putty Impression Material | K781151A |
|-------------------|--------------------------------------------|----------|
| | Aquasil Smart Wetting® Impression Material | K943574 |

DEVICE DESCRIPTION: AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is a very high viscosity, elastomeric impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL consists of two-components (base paste and catalyst paste) which harden to form a base for final impressions. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL with "smart wetting" improves both wetting on the tooth surface and model detail reproduction. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is designed to be used with Aquasil Regular Set Impression Materials.

INTENDED USE: AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.

TECHNOLOGICAL CHARACTERISTICS: All of the components of AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL have been used in DENTSPLY legally marketed predicate devices or found to be safe for dental use.

Due to the similarity of the formulation of AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL to the Aguasil Smart Wetting Impression Material, we believe that additional biocompatibility testing of the new impression material is unnecessary.

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 cytotoxicity. The mixed product was evaluated for dermal toxicity, for imitation, and for mutagenicity.

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

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## 510(k) SUMMARY (cont'd.)

#### TRADE NAME: AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL

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

As an impression material, AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is in the mouth for less than ten minutes.

We believe that the prior use of the components in legally marketed, the similarity of formulation to the predicate devices, the results of 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 EASY MIX PUTTY IMPRESSION MATERIAL for the intended uses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three overlapping profiles suggesting a sense of community or interconnectedness. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. P. Jeffrey Lehn Associate Director Corporate Compliance DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17404

DEC | | 1997

Re : K973781 Trade Name: Aquasil™ Easy Mix Putty Impression Material Requlatory Class: II Product Code: ELW Dated: September 19, 1997 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Lehn

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 regulation (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

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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# PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

510(K) Number: ______________________________________________________________________________________________________________________________________________________________________________

AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL Device Name:

Indications for Use:

AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use _

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________