System Plus is a vinyl polysiloxane dental impression material. It is ideal for one-step impressions to reproduce the structure of a patient's teeth and gums to produce crowns, bridges, inlays, partial and complete dentures, denture repairs, implants and other dental restorations prescribed by a dentist.

Device Description

System Plus is an addition-reaction silicone impression material. This vinyl polysiloxane (VPS) impression material comes in two different viscosities intended to help reproduce the structure of a patient's teeth and gums in order to produce, crowns, bridges, implants, and other dental restorations.

AI/ML Overview

The provided text describes the "System Plus Impression Material," a dental impression material. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study. Therefore, some of the requested information, particularly regarding studies with human participants, AI performance, and expert consensus for ground truth, is not applicable or present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are established by comparing the physical properties of the System Plus Impression Material to a predicate device (Splash! - Discus Dental, Inc.) and relevant ISO standards (ISO 4823). The table below summarizes the key properties and their values for the System Plus material. The "acceptance criteria" are implied by demonstrating comparable performance to the predicate and meeting standard ranges.

Property	Acceptance Criteria (Implied by Predicate/ISO)	Reported Device Performance (System Plus)
Consistency, ISO 4823	Type 0-3 (Splash! range)	Medium Body: Type 2
		Light Body: Type 3
Strain in Compression %	<5% (Splash! <5%)	4.7%
Shrinkage after 24hr	<0.1% (Splash! <0.1%)	<0.1%
Shore A Hardness	Comparable to predicate (Splash! 62-67)	45
Working Time (Including Mixing)	Comparable to predicate (Splash! 55-65 sec)	30-60 seconds
Time in Mouth	Comparable to predicate (Splash! 1 min 15 sec)	3 minutes
Total Setting Time (Including Mixing)	Comparable to predicate (Splash! 2 min 15 sec)	< 4 minutes

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

The document does not describe a test set with a specific sample size in the context of a clinical study with human subjects. The data provenance for the physical properties (e.g., Strain in Compression, Shrinkage, Shore A Hardness) is based on laboratory testing of the material itself, not human subjects. The origin of this data is from Continental Dental Laboratory's internal testing as part of their 510(k) submission. This is not a retrospective or prospective study in the typical clinical sense.

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

This information is not applicable as there is no mention of a test set that required expert ground truth in the context of human outcomes or diagnoses. The "ground truth" for the material's physical properties is established through standardized laboratory testing methods.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of a test set that required adjudication by experts.

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

An MRMC comparative effectiveness study was not conducted. This type of study typically involves multiple human readers evaluating medical images or patient cases, often comparing performance with and without an AI assist. The System Plus Impression Material is a physical dental material, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone study, as defined for an algorithm without human involvement, was not conducted. The "performance" assessment for this device is based on its physical properties.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is based on standardized laboratory measurements and physical property testing (e.g., ISO 4823 for consistency). This is not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set:

This information is not applicable. The System Plus Impression Material is a physical product and does not involve an "algorithm" or a "training set" in the context of machine learning or AI. The product's formulation and manufacturing processes are developed through R&D, not trained on data.

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

This information is not applicable. As stated above, there is no training set for an algorithm. The "truth" for the material's characteristics is based on established scientific principles and material science testing.

Summary

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K 073475

Summary of Safety and Effectiveness

MAR 1 0 2008

System Plus Impression Material

1.	Date of SummaryPreparation:	June 22, 2007
2.	Submitting Firm:	Continental Dental Laboratory
3.	Contact Person:	Jerry Doviack, CDTPresidentContinental Dental Laboratory1873 Western WayTorrance, CA 90501T: (310) 618-8821F: (310) 618-1238
4.	Name of Medical DeviceProprietary Name:	System Plus Impression Material
	Common Name:	Dental Impression Material
	Classification Name:	Impression Material

1. Description of Medical Device:
  System Plus is an addition-reaction silicone impression material. This vinyl polysiloxane (VPS) impression material comes in two different viscosities intended to help reproduce the structure of a patient's teeth and gums in order to produce, crowns, bridges, implants, and other dental restorations.

PROPERTY	MEDIUM BODY	LIGHT BODY
Consistency, ISO 4823	Medium Body, Type 2	Light Body, Type 3
Color	yellow	blue
Working Time(Including Mixing)	30-60 seconds	30-60 seconds
Time in Mouth	three minutes	three minutes
Total Setting Time(Including Mixing)	four minutes	four minutes
Strain in Compression %	4.7%	4.7%
Shrinkage after 24hr	<0.1%	<0.1%
Shore A Hardness	45	45

Physical Properties

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6. Intended Use

This VPS impression material is intended to be placed on an impression tray and used to reproduce the structure of a patient's teeth and gums in order to produce crowns, bridges, implants and other dental restorations. This product is for professional use only by or on the order of a licensed dentist.

7. Substantial Equivalence Determination

Continental Dental Laboratory has determined that System Plus Impression Material is substantially equivalent to:

K052090, Splash! - Discus Dental, Inc.

PRODUCT	COMPANY	ISO 4823	STRAIN INCOMPRESSION	SHRINKAGE	SHORE AHARDNESS
System Plus	ContinentalDental Lab	Type 2-3	<5%	<.1%	45
Splash!	Discus Dental	Type 0-3	2.3-2.5%	<.1%	62-67

Predicate Similarities

Predicate Differences

PRODUCT	COMPANY	WORKING TIME(INC MIXING)	TIME INMOUTH	TOTALSETTINGTIME	SHORE AHARDNESS
System Plus	ContinentalDental Lab	30-60 seconds	3 minutes	< 4 minutes	45
Splash!	Discus Dental	55-65 seconds	1 min 15 sec	2 min. 15 sec	62-67

8. Safety & Effectiveness

Continental Dental Laboratories acknowledges that when used as directed, there are no known harmful reactions or side effects on patients and/or dental personnel using vinyl polysiloxane impression materials.

The company will continue to conduct safety assessments based on further research and analysis to ensure compliance with safety and performance specifications recorded and published for this product.

END OF SECTION

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2008

Ms. Kareen Chamberlain Marketing Director Continental Dental Laboratory 1873 Western Way Torrance, California 90501

Re: K073475

Trade/Device Name: System plus Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 6, 2007 Received: December 18, 2007

Dear Ms. Chamberlain:

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 - Ms. Chamberlain

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.

Sytte Y. Michienond.

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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Indications for Use

510(k) Number (if known): K073475

Device Name: System Plus Impression Material

Range of Indications:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runore

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

510(k) Number: K07345

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).