(163 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental retraction cord, with no mention of AI or ML.
Yes
The device aids in temporary gingival displacement, control of sulcular seepage, and hemorrhage, which are therapeutic actions aimed at managing a condition (gingival tissue displacement, bleeding) during dental procedures.
No
The device is described as a material for temporary retraction of the gingival margin, used to displace gum tissue for dental procedures and aid accurate impressions. It does not perform any diagnostic function.
No
The device description explicitly states it is a "dental retraction material" consisting of "braided or knitted cotton yarn." This is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary retraction of the gingival margin in dental procedures. This is a physical action performed on the patient's tissue.
- Device Description: The device is a physical cord made of cotton yarn used to displace gum tissue. It is used in combination with solutions applied directly to the patient.
- Lack of Diagnostic Purpose: The device does not perform any tests on samples taken from the body (like blood, urine, or tissue samples) to diagnose a condition, monitor a treatment, or screen for diseases. Its purpose is purely mechanical and procedural.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (within the body) during a dental procedure.
N/A
Intended Use / Indications for Use
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.
Product codes
MVL
Device Description
GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are dental retraction materials used to aid accurate impressions of sub-gingival margins by temporary gingival displacement, control sulcular seepage and control hemorrhage. Non-impregnated retraction materials are to be used in combination with an astringent/hemostatic solution of choice. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The non-impregnated retraction materials consists only of braided or knitted cotton yarn soaked with an aqueous surfactant solution and then dried to facilitate absorption of medicament containing retraction solution of dentist's choice into the cotton cord. The braided and knitted cord configurations are available in different sizes to fit the sulcus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margin, sulcus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed dental professionals
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
Non-clinical performance data included Cutting Test, Water Contact Test and Biocompatibility testing.
The following standards were utilized for the non-clinical performance testing:
- ISO 10993-1: 2009 Biological evaluation of medical devices
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in . Vitro Cytotoxicity
Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2017
Kerr Corporation % Mohammad Saad Ansari Regulatory Affairs Specialist II Sybron Dental Specialties 1717 W. Collins Ave Orange, California 92867
Re: K162164
Trade/Device Name: GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord Regulation Number: None Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: December 15, 2016 Received: December 19, 2016
Dear Mohammad Saad Ansari:
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.
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
1
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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K162164
Device Name
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
Indications for Use (Describe)
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K162164 510(k) SUMMARY
- Submitter Information: 1.
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687
| Contact Person: | Mohammad Saad Ansari |
|---|---|
| Telephone Number: | 909-962-5644 |
| Fax Number: | 909-962-5694 |
Date Prepared: January 9, 2017
-
- Device Name:
- Proprietary Name: .
- . Classification Name:
- . CFR Number:
- Device Class: Unclassified .
- . Product Code:
3. Predicate Device:
GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are substantially equivalent to the legally marketed device(s) Microscopy, Division of Neo-Flo, Inc.'s Quicknit Cord, K131799, product code MVL, cleared on January 16th, 2014.
Retraction Cord
872.3275
MVL
GingiKnit+, GingiBraid+, and GingiBraid+
ShortCut Non-Impregnated Retraction Cord
-
- Description of Device:
GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are dental retraction materials used to aid accurate impressions of sub-gingival margins by temporary gingival displacement, control sulcular seepage and control hemorrhage. Non-impregnated retraction materials are to be used in combination with an astringent/hemostatic solution of choice. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The non-impregnated retraction materials consists only of braided or knitted cotton yarn soaked with an aqueous surfactant solution and then dried to facilitate absorption of medicament containing retraction solution of dentist's choice into the cotton cord. The braided and knitted cord configurations are available in different sizes to fit the sulcus.
- Description of Device:
Image /page/3/Picture/15 description: The image contains two figures. The figure on the left shows a black circle surrounded by six white circles. The figure on the right shows a three-dimensional view of a cylinder with a textured surface.
4
-
న. Intended Use:
Retraction Cords are for the temporary retraction of the gingival margins and hemostasis procedures. -
- Indications for Use:
GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.
- Indications for Use:
-
- Description of Safety and Substantial Equivalence:
Technological Characteristics
- Description of Safety and Substantial Equivalence:
The designs of GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are similar to the predicate Quicknit Cord (K131799). They are all Non-Impregnated Retraction Cord products. Neither product contains an additional hemostatic chemical agent. The proposed device includes a surfactant wetting agent.
- Non-Clinical Performance Data 8.
Non-clinical performance data included Cutting Test, Water Contact Test and Biocompatibility testing.
The following standards were utilized for the non-clinical performance testing:
- . ISO 10993-1: 2009 Biological evaluation of medical devices
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in . Vitro Cytotoxicity
| Table 8.1: Predicate and Proposed Device Comparison Table | |||||
|---|---|---|---|---|---|
| Element | Predicate
Quicknit Cord | Proposed GingiKnit+,
GingiBraid+, and ShortCut
with GingiBraid+ Non-
impregnated Cord |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K131799 | K162164 |
| Target Users | Licensed dental professionals | Licensed dental professionals |
| Intended Use | Retraction Cords are for the
temporary retraction of the
gingival margins and hemostasis
procedures. | Retraction Cords are for the
temporary retraction of the
gingival margins and hemostasis
procedures. |
| 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. | GingiKnit+, GingiBraid+, and
GingiBraid+ ShortCut Non-
Impregnated Retraction Cord are
for the temporary retraction of
the gingival margin. The
Retraction Cord is placed in the
sulcus to displace gum tissue for
a small period of time in dental
procedures. |
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| Element | Predicate
Quicknit Cord | Proposed GingiKnit+,
GingiBraid+, and ShortCut
with GingiBraid+ Non-
impregnated Cord |
|--------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------|
| Common Name | Retraction Material | Retraction Material |
| Classification Name | None | None |
| Class | Unclassified | Unclassified |
| Product Code | MVL | MVL |
| Astringent/Hemostatic
Agent | None | None |
| Contact Time | Unknown | Less than 5 minutes |
| Material Composition | 100% Cotton | Cotton and surfactant |
| Material Compatibility | Biocompatibility meets
requirements of ISO 10993 | Biocompatibility meets
requirements of ISO 10993 |
| Configurations | Knitted | Knitted, Braided, Braided with
ShortCut |
9. Clinical Performance Data
Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord.
10. Conclusion as to Substantial Equivalence
The proposed device and the predicate Quicknit Cord (K131799) differ in their configuration, packaging, and delivery method. Neither the predicate nor the proposed devices are impregnated with hemostatic solutions and are primarily composed of cotton material. The proposed device includes a surfactant wetting agent to aid in soaking. The proposed GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord have similarities in select performance characteristics as compared to the predicate. Results of nonclinical testing demonstrate that any noted differences in technological characteristics between the proposed and predicate products to not raise new questions of safety and effectiveness. The proposed product line is substantially equivalent to the predicate Quicknit Cord (K131799) based on design, performance, biocompatibility testing, indications for use and the intended use.