(142 days)
Not Found
No
The device is a dental impression material, and the description focuses on its physical properties and biocompatibility, with no mention of AI or ML.
No
The device is an impression material used to create a model of the oral cavity, not to treat, diagnose, cure, or prevent any disease or condition.
No
Explanation: The device is an impression material used to create a physical copy of the oral cavity (gypsum cast). It does not analyze or interpret medical data to diagnose a disease or condition, but rather aids in the construction of models for study or to create other dental appliances.
No
The device is a dental impression material, which is a physical substance used to create a mold. The description clearly indicates it is a powder and discusses physical and biocompatibility testing, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to take impressions of the oral cavity for the purpose of constructing a gypsum cast. This is a physical process of creating a mold of the patient's anatomy.
- Device Description: It is an impression material, a substance used to capture the shape of the oral cavity.
- No mention of in vitro testing: The description does not involve testing samples (like blood, urine, tissue) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
- Performance Studies: The performance studies focus on physical parameters and biocompatibility, not on diagnostic accuracy or the analysis of biological samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ELW
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist / general dental practice and for orthodontics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data provided includes physical parameters comparing the proposed device (K151535) against two predicate devices (K051207, K011419) and ADA18 requirements.
Physical Parameters:
- Appearance: Powder for all devices.
- Color: Purple for K151535; Fuchsia for predicates.
- Flavor: Bubble-gum for K151535; Red-fruit for predicates.
- Compatibility & Detail Reproduction: Complies for all, meeting 0 - 50 μm requirement.
- Recovery from Deformation: 96% for all, meeting >95% requirement.
- Strain in Compression: 16% for all, meeting 5 - 20% requirement.
- Compressive Strength: > 0.80 Mpa for all, meeting > 0.35 Mpa requirement.
- Deterioration: > 0.60 Mpa for all, meeting > 0.294 MPa requirement.
Biocompatibility: Testing was performed for cytotoxicity (ISO 10993-5), sensitization, and irritation (ISO 10993-10). The test results demonstrated that the proposed device, Cavex Cream Alginate, is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.
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.
1
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
2
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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 Woortman |
| Manager Technical Services | |
| Cavex Holland BV | |
| Phone: +31 (0)235307700 | |
| Email: 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:
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.
Orthotrace ColorChange
| Comparison of | |
|---|---|
| Indications for Use: | K151535 Cavex Holland BV - Cavex Cream Alginate |
| Cavex Cream Alginate is an irreversible hydrocolloid dental |
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.
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
4
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.
5
Performance Data:
| Physical Parameters | Proposed
device | Primary
device | Secondary
device | ADA18
Requirements |
|----------------------------------------|------------------------------------|-----------------------------------------|------------------------------------------|-----------------------|
| | K151535 | K051207 | K011419 | |
| | Cavex
Holland
Cavex
Cream | Cavex
Holland
Cavex
Orthotrace | Cavex
Holland
Cavex
ColorChange | |
| Appearance | Powder | Powder | Powder | |
| Color | Purple | Fuchsia | Fuchsia | |
| Flavor | bubble-gum | red-fruit | red-fruit | |
| Compatibility & Detail
Reproduction | 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