QUICKNIT

K131799 · Microcopy, Div. of Neo-Flo, Inc. · MVL · Jan 16, 2014 · DE

Device Facts

• Record ID: K131799
• Device Name: QUICKNIT
• Applicant: Microcopy, Div. of Neo-Flo, Inc.
• Product Code: MVL · DE
• Decision Date: Jan 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin. The gingival retraction cord is placed in the sulcus (between the gum tissue and your tooth structure) to displace the gum tissue for a small period of time in dental procedures. Professional use is recommended

Device Story

Quicknit Cord is a dental retraction cord used to temporarily displace gingival tissue from the tooth structure. The device is a physical cord, unimpregnated, placed into the gingival sulcus by a dental professional. By creating space between the gum and the tooth, it facilitates dental procedures requiring clear access to the gingival margin. It is a manual, non-powered device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Unimpregnated cord for gingival retraction. Manual, non-powered, mechanical displacement device.

Indications for Use

Indicated for temporary retraction of the gingival margin in dental procedures by displacing gum tissue from the tooth structure. For professional use.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

#### January 16, 2014

Microscopy, Division of Neo-Flo, Inc. Ms. Peggy Gober Quality Manager 3120 Moon Station Road, NW Kennesaw, GA 30144

Re: K131799

Trade/Device Name: Quicknit Regulation Number: None Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: November 12, 2013 Received: November 13, 2013

Dear Ms. Gober:

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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Page 2 -Ms. Gober

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/ResourcesforYou/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,

Image /page/1/Picture/7 description: The image shows the name "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. The letters are black, and the background is white.

for

Erin I. Keith M.S. Acting Division 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 (if known): K 131 799

### Device Name: Quicknit Cord Indications for Use:

Quicknit Cord is unimpregnated cord for the temporary retraction of the gingival margin. The gingival retraction cord is placed in the sulcus (between the gum tissue and your tooth structure) to displace the gum tissue for a small period of time in dental procedures.

Professional use is recommended

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner -\$
Susan Runner DOSPA 2014.01.09
14:23:33 -05'00'

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