K Number
K092384
Device Name
LIQUICORD
Manufacturer
Date Cleared
2009-11-04

(91 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiquiCord is intended for temporary retraction and hemostatsis of the gingival margin during dental procedures such as dental impressions and the seating of temporary and permanent restorations
Device Description
Not Found
More Information

None

Not Found

No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found) point towards a physical dental material.

No
A therapeutic device is used to treat or cure a disease or condition. This device is used for temporary retraction and hemostasis of the gingival margin during dental procedures, which is a supportive rather than a therapeutic function.

No

The device is intended for temporary retraction and hemostasis of the gingival margin, which are therapeutic and procedural support functions, not diagnostic ones. It does not identify or characterize a disease or condition.

No

The summary describes a device intended for temporary retraction and hemostasis of the gingival margin during dental procedures. This function strongly suggests a physical device (e.g., a cord or material) is involved, not solely software. The lack of any mention of software, image processing, AI, or input imaging modality further supports this conclusion.

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

Here's why:

  • Intended Use: The intended use is for "temporary retraction and hemostatsis of the gingival margin during dental procedures". This describes a physical action performed on the patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing a biological sample (blood, urine, tissue, etc.)
    • Providing diagnostic information
    • Using reagents or analytical methods

The device appears to be a physical tool used in a dental procedure.

N/A

Intended Use / Indications for Use

LiquiCord is intended for temporary retraction and hemostatsis of the gingival margin during dental procedures such as dental impressions and the seating of temporary and permanent restorations

Product codes

MVL

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gingival margin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Roger Mastrony Manager Quality Assurance and Regulatory Affairs Centrix Incorporated 770 River Road Shelton, Connecticut 06484

NOV - 4 2009

Re: K092384

Trade/Device Name: LiquiCord Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: October 29, 2009 Received: October 30, 2009

Dear Mr. Mastrony:

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 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

Page 2- Mr. Mastrony

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Susan Rasiner

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number K092384

Device Name: LiquiCord

Indications for Use:

LiquiCord is intended for temporary retraction and hemostatsis of the gingival margin during dental procedures such as dental impressions and the seating of temporary and permanent restorations

Prescription Use (Part 21 CFR 801 Subpart D)

a count of control and the other the contribute with and the work and the many

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and in the same of the comments of the sense and any will be world of a more a

R. Muly for WSP

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

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510(k) Number: K092384