NoCord

K152826 · Centrix, Inc. · ELW · May 27, 2016 · Dental

Device Facts

• Record ID: K152826
• Device Name: NoCord
• Applicant: Centrix, Inc.
• Product Code: ELW · Dental
• Decision Date: May 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord 1. Retracts the gingival tissue to expose the sub-gingival margin 2. Controls gingival bleeding 3. Reproduces the structure of a patient's teeth and gums

Device Story

NoCord is a low-viscosity vinyl polysiloxane (VPS) dental impression material. Used by dental professionals in clinical settings during indirect restoration procedures. Applied as a wash material in a tray/wash technique; simultaneously captures dental anatomy and manages gingival tissue. Functions by physically displacing gingival tissue to expose sub-gingival margins and providing hemostasis to control bleeding. Output is a high-precision physical impression of the patient's teeth and gums, used by dental laboratories to fabricate indirect restorations. Benefits include simplified clinical workflow by combining retraction, hemostasis, and impression-taking into a single step.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Vinyl polysiloxane (VPS) impression material. Low viscosity. Chemical composition includes astringent agents for tissue retraction and hemostasis. Physical form is a paste/viscous material. Standalone device; no software or electronic components.

Indications for Use

Indicated for use as a wash material in tray/wash techniques for indirect dental restorations to retract gingival tissue, control bleeding, and reproduce tooth/gum structure.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Expasyl (K022667)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

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

May 27, 2016

Centrix, Inc. Mr. Greg Moreau Regulatory Affairs/ Ouality Assurance 770 River Road Shelton, CT 06484

Re: K152826

Trade/Device Name: NoCord Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW, MVL Dated: February 16, 2016 Received: February 29, 2016

Dear Mr. Moreau:

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Tina Kiang -

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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## Indications for Use

510(k) Number:

K152826

Device Name: NoCord

Indications for Use:

NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord

- 1. Retracts the gingival tissue to expose the sub-gingival margin
- 2. Controls gingival bleeding
- 3. Reproduces the structure of a patient's teeth and gums

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 subpart D) (21 CFR 801 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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