(144 days)
Knit-Pak+, K132526
Not Found
No
The device description and intended use are for a physical dental retraction cord, and there is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The device is used for temporary retraction and hemostasis during dental procedures, which are generally considered accessory to the main therapeutic or diagnostic procedure (e.g., impression taking), rather than a therapeutic treatment in itself. Its transient nature and role in preparing for other restorative procedures support this.
No
The device is described as a retraction cord for temporary gingival margin retraction and hemostasis procedures, used for displacement of gingival tissues prior to impressions or restorative procedures. It does not mention any function related to diagnosing a disease, condition, or state of health.
No
The device description clearly states it is a "Retraction Cord" made of "cotton fiber" and is "impregnated with Aluminum Potassium Sulfate," indicating it is a physical, material-based device, 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 gingival margins and hemostasis procedures in the mouth. This is a direct application to the patient's body for a physical effect (tissue displacement and bleeding control).
- Device Description: The description details a physical cord impregnated with a chemical, used for a physical manipulation of tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
The device is a dental material used for a procedural purpose within the oral cavity, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures.
Product codes (comma separated list FDA assigned to the subject device)
MVL
Device Description
Dental retraction materials are used to aid in creating accurate impressions of subgingival margins by temporary gingival displacement, and control of sulcular seepage and hemorrhage. Cords are impregnated with Aluminum Potassium Sulfate. The braided GingiBraid+ and the knitted GingiKnit+ are made of cotton fiber with a different color strand running through the cord for identification of the diameter. Retraction Cords have a yellow background color for medicament identification. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The braided and knitted cord configurations are available in different sizes to fit the sulcus. There have been no prior submissions on the subject product line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margins, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Non-clinical performance data included Stability, 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. Results of nonclinical testing demonstrate that the proposed GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction cord has similarities in select performance characteristics as compared to the predicate.
Clinical Performance Data: Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Knit-Pak+, K132526
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
Kerr Corporation % Mohammad Ansari Regulatory Affairs Specialist II Sybron Dental Specialties 1717 W. Collins Ave. Orange, California 92867
Re: K162536
Trade/Device Name: Gingiknit+, Gingibraid+, Gingibraid+ Shortcut, and Unibraid+ Impregnated Aluminum Potassium Sulfate Retraction Cord Regulation Number: 21 CFR Regulation Name: (Not A Regulation) Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: January 6, 2017 Received: January 9, 2017
Dear Mohammad 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
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.
Sincerelv.
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
2
Indications for Use
510(k) Number (if known) K162536
Device Name
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium
Indications for Use (Describe)
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative 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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K162536 510(k) SUMMARY
-
- Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867
| Contact Person: | Mohammad Saad Ansari |
|---|---|
| Telephone Number: | 909-962-5644 |
| Fax Number: | 909-962-5694 |
January 27, 2017 Date Prepared:
-
- Device Name:
- . Proprietary Name:
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
- . Classification Name: Retraction Cord CFR Number: 872.3275 . • Device Class: Unclassified
- Product Code: .
MVL
Predicate Device: 3.
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are substantially equivalent to the legally marketed device(s) Premier Dental Products Co.'s Knit-Pak+, K132526, cleared on November 26, 2013.
4. Description of Device:
Dental retraction materials are used to aid in creating accurate impressions of subgingival margins by temporary gingival displacement, and control of sulcular seepage and hemorrhage. Cords are impregnated with Aluminum Potassium Sulfate. The braided GingiBraid+ and the knitted GingiKnit+ are made of cotton fiber with a different color strand running through the cord for identification of the diameter. Retraction Cords have a yellow background color for medicament identification. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The braided and knitted cord configurations are available in different sizes to fit the sulcus. There have been no prior submissions on the subject product line.
- న. Intended Use:
The intended use of GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord is for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
4
-
- Indications for Use:
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures.
- Indications for Use:
-
- Description of Substantial Equivalence:
Technological Characteristics
- Description of Substantial Equivalence:
The designs of GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are similar to the predicate KnitPak+(K132526). The braided or knitted cotton also contains a surfactant and the chemical Aluminum Potassium Sulfate for hemostasis. The braided retraction material is made of cotton fiber and a solid cord that provides a strong physical retraction and will not split or collapse in the sulcus. It can be used with any type of packing instrument. The knitted retraction cord is constructed by knitting many tiny loops together to form a long interlocking chain that places easily without fraying or memory. The GingiKNIT+ Aluminum Potassium Sulfate Retraction Cord conforms to the sulcus with a gentle, outward force. The knitted retraction cord will cut cleanly if touched by a high-speed cutting instrument.
-
- Non-Clinical Performance Data
Non-clinical performance data included Stability, Cutting Test, Water Contact Test and Biocompatibility testing.
- Non-Clinical Performance Data
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
Knit-Pak+ | Proposed
GingiKnit+, GingiBraid+,
GingiBraid+ Shortcut, and
UniBraid+ impregnated
Aluminum Potassium Sulfate
Retraction Cord |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K132526 | K162536 |
| 510(k) Sponsor | Premier Dental Company
Products | Sybron Dental Specialties |
| Target Users | Licensed dental professionals | Licensed dental professionals |
| Element | Predicate
Knit-Pak+ | Proposed
GingiKnit+, GingiBraid+.
GingiBraid+ Shortcut, and
UniBraid+ impregnated
Aluminum Potassium Sulfate
Retraction Cord |
| Intended Use | The intended use of KnitPak+ is
for the temporary retraction and
hemostasis of the gingival margin
during dental procedures such as,
but not limited to,
dental impressions, seating of
temporary and permanent
restorations, restorations of
cavities and placement of a
rubber dam. | The intended use of GingiKnit+,
GingiBraid+, GingiBraid+
Shortcut, and UniBraid+
impregnated Aluminum Potassium
Sulfate Retraction Cord is for the
temporary retraction and
hemostasis of the gingival margin
during dental procedures such as,
but not limited to, dental
impressions, seating of temporary
and permanent restorations,
restorations of cavities and
placement of a rubber dam. |
| Indications for Use | Knit-Pak+, a prescription-only,
Aluminum Chloride Hexahydrate
impregnated cord is used for
temporary chemo-
mechanical 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. | GingiKnit+, GingiBraid+,
GingiBraid+ Shortcut, and
UniBraid+ impregnated Aluminum
Potassium Sulfate Retraction Cord
are for the temporary retraction of
the gingival margins and
hemostasis procedures. The
Retraction Cord is placed in the
sulcus to displace the gingival
tissues for a short period prior to
making an impression or for other
restorative procedures. |
| Common Name | Retraction Material | Retraction Material |
| Classification Name | None | None |
| Class | Unclassified | Unclassified |
| Product Code | MVL | MVL |
| Astringent/Hemostatic
Agent | Aluminum Chloride | Aluminum Potassium Sulfate |
| Additional Ingredients | Cotton (others unknown) | Cotton, Silwet (surfactant) |
| Contact Time | Less than 5 minutes | Less than 5 minutes |
| Material Compatibility | Biocompatibility meets
requirements | Biocompatibility meets
requirements |
| Configurations | Knitted Cord | Retraction Cord available as:
Knitted, Braided, Braided with
ShortCut, Precut Single Unit
Dose |
| Element | Predicate
Knit-Pak+ | Proposed
GingiKnit+, GingiBraid+,
GingiBraid+ Shortcut, and
UniBraid+ impregnated
Aluminum Potassium Sulfate
Retraction Cord |
| Amount | 100 inches (254 cm) | 6 foot total or 2 inch single unit |
| Packaging | Bottles | Bottles
Specialized ShortCut+ System
Single Unit Dose 2 inch |
5
6
9. Clinical Performance Data
Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord.
-
- Conclusion as to Substantial Equivalence
The subject device and its predicate KnitPak+ differ in their configuration and hemostatic agent. However, the technological characteristics of the subject GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are virtually identical to the predicate, KnitPak+(K132526), and both devices have the same device intended use. Both devices have retraction as their primary function. The subject device uses the chemical Aluminum Potassium Sulfate while the predicate uses Aluminum Chloride. Results of nonclinical testing demonstrate that the proposed GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction cord has similarities in select performance characteristics as compared to the predicate. Any noted differences in technological characteristics between the proposed and predicate products do not raise new questions of safety or effectiveness.
- Conclusion as to Substantial Equivalence
The subject deviceis substantially equivalent to the predicate KnitPak+(K132526), based on design, performance, biocompatibility testing, and the intended use.