K Number
K970594
Device Name
KALGINATE IMPRESSION MATERIAL
Manufacturer
Date Cleared
1997-03-31

(41 days)

Product Code
Regulation Number
872.3660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient's teeth and oral tissues.
Device Description
Kalginate ® is a powdered material, that is mixed with water and placed in the patients oral cavity. It contains alginate, an essential gel forming material, that reacts with water to form an elastic material suitable for making impressions of the patients teeth and oral tissues.
More Information

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Not Found

No
The device description and performance studies focus on the material properties and stability of a dental impression material, with no mention of AI or ML.

No
This device is an impression material used to obtain impressions of the patient's teeth and oral tissues; it does not treat or cure any condition.

No

Explanation: The device, Kalginate®, is an impression material used to obtain physical impressions of teeth and oral tissues. This process is for replication, not for diagnosing a disease or condition.

No

The device is a physical material (powder) that is mixed with water to form an impression material, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to obtain impressions of teeth and oral tissues. This is a physical process for creating a mold, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
  • Device Description: The description details a material mixed with water to form an elastic impression material. This aligns with a physical impression process, not a diagnostic assay.
  • Lack of Diagnostic Information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
  • Anatomical Site: While the oral cavity is mentioned, the device is used within the body to create a physical impression, not to analyze samples taken from the oral cavity for diagnostic purposes.

IVD devices are typically used to examine specimens such as blood, urine, tissue, or other body fluids to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Kalginate ® does not fit this description.

N/A

Intended Use / Indications for Use

The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient's teeth and oral tissues.

Product codes

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Device Description

Kalginate ® is a powdered material, that is mixed with water and placed in the patients oral cavity. It contains alginate, an essential gel forming material, that reacts with water to form an elastic material suitable for making impressions of the patients teeth and oral tissues.

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's teeth and oral tissues

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Accelerated shelf life testing was conducted on a batch of the new Kalginate ® Impression Material. The batch was mixed and processed using Research and Development equipment. Test samples from the batch were aged for 3 months at 23° and 40° C. The elevated temperature represents a 2 year shelf life. A summary of the tests and the results is discussed in Appendix 4. The results show no stability difference between the new and old Kalginate @ Impression Material formulations.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

The Company's Kalginate ® Impression Material, a preamendment device.

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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

K970594

Kalginate @ 510(K) SUMMAR

1. Name and Address of Applicant

Teledyne Water Pik 1730 East Prospect Road Fort Collins, CO 80553-0001

Contact Person

Michael J. Ryan

FAX Telephone

(970) 221-8662 (970) 221-8252

Prepared on 7 Feb 1997

2. Name of the Device

Classification Name - Dental Impression Material.

Common Name - Alginate Impression Material.

Trade Name - Kalginate ® Impression Material.

3. Legally Marketed Device for Substantial Equivalence Determination

The Company's Kalginate ® Impression Material, a preamendment device.

4. Description of the Device

Kalginate ® is a powdered material, that is mixed with water and placed in the patients oral cavity. It contains alginate, an essential gel forming material, that reacts with water to form an elastic material suitable for making impressions of the patients teeth and oral tissues.

5. Intended use of the device

The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient's teeth and oral tissues.

1

6. Material/Technological Characteristics

The color pigment material for the Company's Kalginate ® Impression Material, Valencia Orange, is changed to Red Pigment # 38. A specification sheet and a Material Safety Data Sheet are enclosed.

7. Performance data

Performance

Accelerated shelf life testing was conducted on a batch of the new Kalginate ® Impression Material. The batch was mixed and processed using Research and Development equipment. Test samples from the batch were aged for 3 months at 23° and 40° C. The elevated temperature represents a 2 year shelf life. A summary of the tests and the results is discussed in Appendix 4. The results show no stability difference between the new and old Kalginate @ Impression Material formulations.

Biocompatibility

Test results from a cheek Pouch Mucosal Irritation Histopathology Study indicates that the Kalginate ® formulation with the Red Pigment #38 is non-irritating to the cheek pouch mucosa of hamsters.