Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

Device Description

Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.

AI/ML Overview

Here's an analysis of the provided information regarding the Splash!® Dental Impression Material, focusing on acceptance criteria and the supporting study details:

Device: Splash!® Dental Impression Material

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Splash!® Dental Impression Material are primarily based on demonstrating substantial equivalence to predicate devices across various physical and chemical properties relevant to dental impression materials. The "acceptance criteria" are implied by the ranges and values observed in the predicate devices which the new device aims to meet or perform comparably to.

Property	Acceptance Criteria (Implied from Predicates)	Splash!® Dental Impression Material Performance
Material Type (ISO 4823)	Type 0-3 (Consistent with Precision) or Type 1-3 (Aquasil, P2 Polyether)	Type 0-3
Recovery from Deformation	>98.0% (Aquasil) or 97.5% - 99.6% (P2, Precision)	99.2% - 99.5%
Shrinkage	<0.50% (Aquasil) or 0.40 - 0.50% (P2 Polyether) or <0.10% (Precision)	Max. <0.10%
Working Time	45 - 120 seconds (Range of Predicates)	55 - 65 seconds
Hardness (Shore A)	44 - 69 (Range of Predicates)	62 - 67
Strain in Compression	1 - 10% (Range of Predicates)	2.3 - 2.5%
Storage Conditions	59° - 80° F (15° - 25° C) (Range of Predicates)	59° - 78° F (15° - 25° C)

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample sizes for the "in-house testing" conducted on the Splash!® Dental Impression Material. It only mentions "Evaluations and in-house testing."

Sample Size: Not specified.
Data Provenance: The testing was "in-house testing" by Discus Dental, Inc. This typically means the data was generated internally by the manufacturer. The country of origin is not explicitly stated for the testing, but Discus Dental, Inc. is a US-based company, suggesting the testing likely occurred in the US. The data is retrospective in the sense that it's presented to support an existing product, but the tests themselves would have been conducted prospectively on samples of the material.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The testing described focuses on physical and chemical properties of the material, not on interpretations or diagnoses that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The testing is for physical properties, not for diagnostic outcomes requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable/provided. The device is a dental impression material, not an AI-assisted diagnostic tool or system that would involve human readers interpreting images or data with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable/provided. The device is a physical material, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of the Splash!® Dental Impression Material is based on standardized test methods for physical and chemical properties of dental impression materials. These methods define objective measurements for properties like recovery from deformation, shrinkage, working time, hardness, and strain in compression. The "truth" is established by the results of these standardized tests.

8. Sample Size for the Training Set

This information is not applicable/provided. As a physical material, there isn't a "training set" in the sense of machine learning algorithms. The material's formulation and manufacturing processes are likely developed through research and development, but this is distinct from an algorithmic training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated above (not an AI/algorithmic device). The development of the material's properties would be guided by material science principles and performance targets, often benchmarked against existing successful products (like the predicates mentioned).

Summary

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K052090

AUG 5 - 2005

Summary of Safety and Effectiveness II.

Date of Summary:

Splash!® Dental Impression Material

1. Date of Summary July 15, 2005 Preparation: Discus Dental, Inc. 3. Submitting Firm: 4. Contact Person Suzanne Ridgway Regulatory Affairs Coordinator Discus Dental, Inc. 8550 Higuera Street Culver City, CA 90232 310.845-8345 - phone 310.845.8647 - fax 5. Name of Medical Device Proprietary Name: Splash!® Dental Impression Material Common/Usual Name: Dental Impression Material
- Classification Name: Impression Material
1. Description of Medical Device

1. Intended Use

Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

1. Substantial Equivalence Determination
  Evaluations and in-house testing of the new Splash!® Dental Impression Material device by Discus Dental, Inc. have shown this device to be substantially equivalent to the following commercially marketed impression materials:

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Predicate Device(Primary)	Company	510(k) No.
Precision VPS ImpressionMaterial	Discus Dental	K040053
Predicate Device(Secondary)	Company	510(k) No.
P2 Polyether	Heraeus Kulzer Inc	K030318
Aquasil Smart Wetting	Denstply, Intl.	K021416

Predicate Similarities

Product	Company	ISO 4823	Recovery fromDeformation	Shrinkage	StorageConditions
Splash!	DiscusDental	Type 0-3	99.2- 99.5%	Max.<0.10%	59° -78° F(15° -25° C)
Aquasil	Dentsply	Type 1-3	>98.0%	<0.50%	65° -80° F(18° -25° C)
P2 Polyether	HeraeusKulzer	Type 1-3	97.5 - 98.0%	0.40 -0.50%	65° -80° F(18° -25° C)
Precision	DiscusDental	Type 0-3	99.3- 99.6%	Max.<0.10%	59° -78° F(15° -25° C)

Predicate Differences

Product	Company	Working time	Hardness (Shore A)	Strain in Compression	Shrinkage	Storage Conditions
Splash!	Discus Dental	55 sec - 65 sec	62- 67	2.3 - 2.5%	Max.<0.10%	59 o -78o F (15o -25o C)
Aquasil	Dentsply	75 sec - 105 sec	Data Not Available	1 - 5%	<0.50%	65o -80o F (18o -25o C)
P2 Polyether	Heraeus Kulzer	120 sec.	44 - 64	4.3 - 10%	0.40 - 0.50%	65o -80o F (18o -25o C)
Precision	Discus Dental	45 - 105 sec	44 - 69	2.1 - 4.5%	0.10%	59o -78o F (15o -25o C)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

Discus Dental, Incorporated C/O Dr. Alfredo J. Quattrone Responsible Third Party Official California Department of Health Services Food & Drug Branch P.O. Box 997 413 Sacramento, California 95899-74413

Re: K052090

Trade/Device Name: Splash! Impression Material Device Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 26, 2005 Received: August 2, 2005

Dear Dr. Quattrone:

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 - Dr. Quattrone

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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sufitte y. Michan Oms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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V. Indications for Use Statement

510(k) Number:

Device Name: Splash! Impression Material

... .

Intended Use

Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR Section 801.109)

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Over-The-Counter Use __

Sper Suaser

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devi

510(k) Number: K052040

Discus Dental, Inc.

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).