← Product Code MVL · K132526 # KNIT-PAK+ (K132526) _Premier Dental Products Co. · MVL · Nov 26, 2013 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K132526 ## Device Facts - **Applicant:** Premier Dental Products Co. - **Product Code:** MVL - **Decision Date:** Nov 26, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord is used for temporary chemo-mcchanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever hemostasis and retraction is required. ## Device Story Knit-Pak+ is a dental retraction cord impregnated with Aluminum Chloride Hexahydrate. Used by dental professionals in clinical settings to facilitate gingival tissue retraction and hemostasis. The cord is placed around the gingival margin of a tooth; the mechanical pressure combined with the chemical agent (Aluminum Chloride) retracts tissue and controls bleeding. This provides a clear field for dental impressions or cavity preparation. The device is a single-use, non-electronic consumable. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Dental retraction cord impregnated with Aluminum Chloride Hexahydrate. Non-electronic, mechanical/chemical action. No software or energy source. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 November 26, 2013 Premier Dental Company Products Mr. Vincent D'alessandro Regulatory Manager 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462 Re: K132526 Trade/Device Name: Knit-Pak+ Regulation Number: NONE Regulation Name: NONE Regulatory Class: Unclassified Product Code: MVL Dated: September 25, 2013 Received: September 26, 2013 Dear Mr. D'alessandro: 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 I the general bentlering 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}------------------------------------------------ ## Page 2 - Mr. D'alessandro 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 (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" (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, Image /page/1/Picture/6 description: The image contains the words "Kwame Ulmer" in a stylized font. The text is arranged in two lines, with "Kwame" on the top line and "Ulmer" on the bottom line. There is a logo to the right of the text, which appears to be a geometric shape, possibly a triangle, with some internal patterns or lines. The overall image has a somewhat textured or patterned appearance, possibly due to the font style or the way the image was created. for Erin 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 {2}------------------------------------------------ ## CONFIDENTAL 1710 Romano Drive, Plymouth Mecting, PA 19462 U.S.A 888-773-6872 / 610-239-6000 211 W. DIS.miss Com ## Indications for Use 510(k) Number (if known): K132526 Device Name: Knit-Pak+ Indications for Use: Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord is used for temporary chemo-mcchanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever hemostasis and retraction is required. Prescription Use ______ AND/OR Over-The-Counter Use (2) CFR 801 Subpart C) (Part 21 CFR 80) Subpart D) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runner Mary S. Runner -S DDS, MA 2013.11.26 11:34:09 -05'00' Section 4 Page 1 15- 25-3 --- **Source:** [https://fda.innolitics.com/device/K132526](https://fda.innolitics.com/device/K132526) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com