Cavex Cream Alginate is an irreversible hydrocolloid dental impression material used by the dentist for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions.

Device Description

Cavex Cream Alginate impression material is an impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a purple colored powder with bubble gum flavor.

AI/ML Overview

This document is a 510(k) summary for the Cavex Cream Alginate impression material. It demonstrates substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance for Cavex Cream Alginate

Physical Parameters	Acceptance Criteria (ADA 18 Requirements)	Reported Device Performance (Cavex Cream Alginate - K151535)
Appearance	N/A	Powder
Color	N/A	Purple
Flavor	N/A	bubble-gum
Compatibility & Detail Reproduction	0 - 50 µm	Complies
Recovery from Deformation	>95 %	96 %
Strain in Compression	5 - 20 %	16 %
Compressive Strength	> 0.35 MPa	> 0.80 MPa
Deterioration (This likely refers to tear strength or similar, but is labeled as "Deterioration" in the table)	> 0.294 MPa	> 0.60 MPa

Note: The FDA 510(k) summary explicitly states that the device was deemed "substantially equivalent" based on this performance data and comparison to predicate devices, thus demonstrating it meets the necessary criteria for market entry.

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

The document does not specify the sample size used for the performance testing of the Cavex Cream Alginate or its predicate devices.
The data provenance is also not explicitly stated as country of origin or whether it's retrospective or prospective. However, given that the submitter is "Cavex Holland BV" located in Haarlem, The Netherlands, it's highly probable the testing was conducted in The Netherlands or by a laboratory collaborating with a Dutch company. The testing seems to be laboratory-based physical performance testing rather than clinical data.

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

This document describes performance testing of material properties, not clinical diagnostic accuracy. Therefore, there were no experts used to establish "ground truth" in the context of clinical interpretation, as would be the case for an AI-powered diagnostic device. The "ground truth" for the material properties would be established by standardized laboratory testing procedures and reference standards (e.g., ADA Specification No. 18).

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert interpretations. The performance data is derived from objective physical property measurements.

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

Not applicable. This document pertains to traditional dental impression material, not an AI-powered device, and therefore no MRMC study was conducted or is relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (impression material), not an algorithm or AI-powered device.

7. Type of Ground Truth Used

The ground truth used for performance assessment are the established physical property requirements for alginate impression materials, specifically those outlined in ADA (American Dental Association) Specification No. 18. This specification provides objective, measurable criteria for various properties like detail reproduction, recovery from deformation, strain in compression, compressive strength, and tear strength (likely referred to as "deterioration" here). The reported values are compared directly against these quantitative benchmarks.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device that does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of device.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 28, 2015

Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS

Re: K151535

Trade/Device Name: Cavex Cream Alginate Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: September 25, 2015 Received: September 28, 2015

Dear Mr. Woortman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Submitter/Manufacturer:	Cavex Holland BV
Establishment:	Fustweg 5, 2031CJ Haarlem, The Netherlands
Registration number:	9614573
Owner/operator number:	9033296
Primary Contact Person:	Richard WoortmanManager Technical ServicesCavex Holland BVPhone: +31 (0)235307700Email: r.woortman@cavex.nl

Device:

Trade name:	Cavex Cream Alginate
Common use:	Impression Material
Classification Names:	Material, Impression
Regulation Number:	CFR 872.3660
Product Code:	ELW
Primary Predicate:	K051207	Cavex Holland	Cavex
Secondary Predicate:	K011419	Cavex Holland	Cavex

Device Description:

Orthotrace ColorChange

Comparison of
Indications for Use:	K151535 Cavex Holland BV - Cavex Cream Alginate
	Cavex Cream Alginate is an irreversible hydrocolloid dental

K051207 Cavex Holland BV - Cavex Orthotrace

Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in an attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, Cavex Orthotrace is particularly suited for orthodontics

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K011419 Cavex Holland BV - Cavex ColorChange

Cavex ColorChange is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions, etc. Cavex ColorChange has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.

Indications for Use Discussion:

Cavex Cream Alginate is comparable to other irreversible hydrocolloid impression materials on the market, such as Cavex Orthotrace (K051207) and Cavex ColorChange (K011419). The devices have the same intended use and - except for minor differences in composition to achieve certain features such as rapid setting or changes in color - employ the same alginate-based hydrocolloid chemistry. All three products may be employed in the same clinical applications. The difference between Cavex Cream Alginate and the declared predicate devices lie in the selection and relative percentages of the additives, all of which are common for irreversible-hydrocolloid impression materials.

Technical Characteristics: The technology for the proposed device Cavex Cream Alginate is comparable to the predicate device. Basically the alginate, a soluble salt of alginic acid (extracted from brown seaweed), serves as the thickener for water. It reacts chemically with calcium sulphate to make the paste harden into a solid impression. The fillers (diatomaceous earth) give the mixture its mechanical strength.

A retarder, sodium pyrophosphate, is used for achieving the required hardening-time, sufficient to mix, apply and take a proper impression and setting time in the mouth. Besides, stabilizers and pigments are added.

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Performance Data:

Physical Parameters	Proposeddevice	Primarydevice	Secondarydevice	ADA18Requirements
	K151535	K051207	K011419
	CavexHollandCavexCream	CavexHollandCavexOrthotrace	CavexHollandCavexColorChange
Appearance	Powder	Powder	Powder
Color	Purple	Fuchsia	Fuchsia
Flavor	bubble-gum	red-fruit	red-fruit
Compatibility & DetailReproduction	Complies	Complies	Complies	0 - 50 μm
Recovery from Deformation	96	96	96	>95 %
Strain in Compression	16	16	16	5 - 20 %
Compressive Strength	> 0.80	>0.80	>0.80	> 0.35 Mpa
Deterioration	> 0.60	> 0.60	> 0.60	> 0.294 MPa

Biocompatibility:

The proposed device Cavex Cream Alginate impression material, the primary predicate device and the secondary device contacts directly with the oral mucosa (3 - 5 minutes) therefore they are categorized as surface contact devices with limited contact duration. Testing was performed for cytoxicity (ISO 10993-5), sensitization and irritation (ISO10993-10). The test results demonstrated that the proposed device Cavex Cream Alginate is biocompatible.

Conclusion:

The technical characteristics, material composition, principles of operation and indications for use of the proposed device Cavex Cream Alginate (K151535) is comparable to the predicate device. Therefore, Cavex Holland BV considers that Cavex Cream Alginate Impression Material is substantially equivalent to the predicate device.

Richard Woortman Manager Technical Services Cavex Holland BV

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).