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 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.

AI/ML Overview

The provided text is a 510(k) Summary for a dental impression material. It describes the device, its intended use, and its technological characteristics. However, it does NOT contain the detailed information necessary to complete the requested table regarding acceptance criteria and a study proving the device meets those criteria, especially for a medical AI/ML device.

The document discusses biocompatibility testing performed on a predicate device (Aquasil Smart Wetting Impression Material, K943574) and uses that information to justify that additional biocompatibility testing for the new device (AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL) is unnecessary due to similarity in formulation and components.

Here's a breakdown of what can be extracted and what cannot:

Information that CANNOT be extracted from the provided text for an AI/ML device context:

Acceptance Criteria Table and Reported Device Performance (for AI/ML metrics): The document discusses biocompatibility of the impression material, not performance metrics like sensitivity, specificity, AUC, etc., that would be relevant for an AI/ML device.
Sample size for the test set and data provenance: No such information is present as the "study" is about biocompatibility of a dental material.
Number of experts and their qualifications for ground truth: Not applicable for this type of device.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study information: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used (for disease detection/diagnosis): Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information that CAN be inferred or extracted related to the device's "study" for biocompatibility:

The "study" referenced is largely a series of biocompatibility tests performed on a predicate device (Aquasil Smart Wetting Impression Material, K943574) and the components of the new device. The new device's acceptance is based on the similarity to its predicate and the prior testing of the predicate.

Here's an attempt to structure what's available, acknowledging its limitations for the requested format:

1. Table of Acceptance Criteria and Reported Device Performance (Biocompatibility related)

Acceptance Criteria (Implied for Biocompatibility)	Reported Device Performance (from predicate device K943574)
Cytotoxicity: Acceptable cytotoxicity level	- Base pastes: moderate cytotoxicity.
	- Catalyst pastes: non-cytotoxic.
	- Mixed product: cytotoxicity persisted, but recorded lower value than Reprosil® Impression Material.
Mutagenicity: Non-mutagenic	- Mixed product (Ames Mutagenicity Test): non-mutagenic.
Acute Dermal Toxicity: Non-toxic	- Mixed product (Acute Dermal Toxicity Test): non-toxic.
Irritation: Non-irritant	- Mixed product (Hamster Cheek Pouch Irritation Study): non-irritant.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for these biocompatibility tests.
Data provenance: The tests were reported in K943574, likely conducted by the manufacturer, but specific country of origin or retrospective/prospective nature isn't detailed for these tests. The results are from prior testing of a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for these types of biocompatibility tests. Standardized laboratory procedures are followed.

4. Adjudication method for the test set

Not applicable for these types of biocompatibility tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This is a biocompatibility assessment of a material, not a diagnostic AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a material; there is no algorithm.

7. The type of ground truth used

For biocompatibility:
- Cytotoxicity: Measured cellular response in vitro.
- Mutagenicity: Ames test results (bacterial mutation rates).
- Toxicity: Animal model response (dermal toxicity).
- Irritation: Animal model response (hamster cheek pouch).
- These are standard biological endpoints.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or training set for this device.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device and its "Proof of Safety/Effectiveness" based on the document:

The device, AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL, is a two-component elastomeric impression material. Its safety and effectiveness are supported primarily by its substantial equivalence to predicate devices, particularly "Aquasil Smart Wetting® Impression Material" (K943574). The justification relies on:

Identical Components: All components have been used in legally marketed predicate devices or are considered safe for dental use.
Formulation Similarity: Due to the similarity in formulation to the Aquasil Smart Wetting Impression Material (K943574), additional biocompatibility testing of the new material was deemed unnecessary.
Predicate Device Biocompatibility Testing: The predicate device (K943574) underwent various biocompatibility tests:
- Cytotoxicity: Base pastes showed moderate cytotoxicity, catalyst pastes were non-cytotoxic. The mixed product showed persistent but lower cytotoxicity than another predicate (Reprosil®).
- Mutagenicity (Ames Test): Mixed product was non-mutagenic.
- Acute Dermal Toxicity Test: Mixed product was non-toxic.
- Hamster Cheek Pouch Irritation Study: Mixed product was non-irritant.
Limited Exposure Time: The material is in the mouth for less than ten minutes, which is considered a factor supporting its safety with the established biocompatibility profile.

In essence, the document presents a biocompatibility assessment based on prior testing of a substantially equivalent predicate device, rather than a performance study of an AI/ML diagnostic or treatment planning system.

Summary

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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 (717) 845-7511 Fax 1717 854-2343

P. J. Lehn Telefax (717) 849-4343

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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.3660 Impression material.

(a)
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.(b)
Classification. Class II (Special Controls).