Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and physical properties of the retraction material, with no mention of AI or ML.

Therapeutic

No.
The device is used to temporarily retract gingival margins and control bleeding in preparation for dental procedures, which are temporary actions and not intended to cure, mitigate, treat, or prevent disease.

Diagnostic

No

The device is used for temporary retraction of gingival margins and hemostasis procedures, which are therapeutic or preparatory actions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like solutions, gels, cotton cord, and cotton pellets, which are hardware. The performance studies also focus on physical properties and biocompatibility, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for temporary retraction of gingival margins and hemostasis procedures in the mouth during dental procedures. This is a direct interaction with the patient's tissues.
Device Description: The device is a material (cord or pellets) impregnated with a chemical (aluminum chloride) that is applied to the patient's gingival tissues.
Lack of In Vitro Testing: The description of the device and its use does not involve testing samples outside of the body (in vitro). The performance studies described are related to the physical properties and biocompatibility of the material, not diagnostic testing of biological samples.

IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Aluminum Chloride impregnated retraction material are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is place 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

As part of a tissue management procedure, Styptin, Hemogin-L, Hemodettes, and GingiGEL are aluminum chloride containing astringent/ hemostatic solutions and gels that are intended to be supplied with gingival retraction cord or cotton pellets that are either pre-impregnated or for end-user impregnation by soaking the cords or cotton pellets in these solutions. The aluminum chloride impregnated retraction material is then packed into the sulcus to temporarily displace gingival tissue to expose the sub-gingival margins and control sulcular seepage and hemorrhage for impression taking and other restorative treatments. The supplied retraction material is available as an aqueous aluminum chloride solution or gel and either unit-dose 2"-pieces of braided cotton cord, braided cotton-polyester cord, or unit-dose cotton pellets.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 included aluminum chloride content assessment, shelf life assessment, visual inspection, material composition analysis, cutting test, water contact test, and biocompatibility assessment incorporating risk-to-benefit ratio analysis. The performance testing performed on Styptin, Hemogin-L, Hemodettes, and GingiGEL impregnated Aluminum Chloride Retraction Cord product line was tested and validated to the greatest challenge ("worst-case") within the Kerr Corporation portfolio of retraction cord products. The data from these tests substantiate that the proposed Styptin. Hemogin-L. Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cords are substantially equivalent to the predicate devices. Testing was conducting in accordance with the following standards: ISO 10993-1: 2009 (Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing Within a Risk Management Process), ISO 10993-5: 2009 (Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity), ISO 7405: 2008 (Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry). Clinical performance testing has not been performed for the proposed device.

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.

K162536

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.

K050180, K123215

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

Regulation Number and Section

N/A

Summary

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

August 8, 2017

Kerr Corporation c/o Mohammad Saad Ansari Regulatory Affairs Specialist II Sybron Dental Specialties 1717 W. Collins Ave. Orange, California 92867

Re: K162948

Trade/Device Name: Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials

Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: July 25, 2017 Received: July 26, 2017

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 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

1

the quality systems (OS) 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,

Mary S. Runner -S

for Lori Wiggins 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) K162948

Device Name

Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride impregnated Retraction Cord/ Materials

Indications for Use (Describe)

Aluminum Chloride impregnated retraction material are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is place 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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510(k) SUMMARY for Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride impregnated Retraction Materials K162948

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:

Applicant Information: A.

Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687 USA Fax: 909-962-5694

Correspondent Contact Information:

Mohammad Saad Ansari Regulatory Affairs Specialist II Tel:714-516-7793 Fax:909-962-5694

Date Prepared: August 7, 2017

B. Subject Devices:

Table 5.1: Proposed Devices- Aluminum Chloride Impregnated Retraction Cords/ Materials

| Trade Name | Styptin, Hemogin-L, Hemodettes, and GingiGEL
Aluminum Chloride impregnated Retraction Cord/
Materials |
|-------------------|-------------------------------------------------------------------------------------------------------------|
| Regulation Number | Not Applicable |
| Common Name | Retraction Cord |
| Device Class | Unclassified |
| Product Code | MVL |
| Panel | Dental |

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C. Predicate Devices:

Elements	Primary Predicate	Reference Predicate	Reference Predicate
Trade Name	GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
and UniBraid+
impregnated
Aluminum Potassium
Retraction Cord	Expa-syl	ViscoStat Clear
(Manufacturer
recommends using in
conjunction with non-
impregnated retraction
cord.)
510(k) Sponsor	Sybron Dental
Specialties	Sybron Dental
Specialties	Ultradent Products Inc.
/ OraTech LLC
510(k) #	K162536
(February 3, 2017)	K050180
(February 11, 2005)	K123215
(February 5, 2013)
Regulation
Number	Not Applicable	Not Applicable	Not Applicable
Common Name	Retraction Material	Retraction Material	Retraction Material
Device Class	Unclassified	Unclassified	Unclassified
Product Code	MVL	MVL	MVL
Panel	Dental	Dental	Dental

Table 5.2: Predicate Devices: Primary and Reference

D. Description of Device:

As part of a tissue management procedure, Styptin, Hemogin-L, Hemodettes, and GingiGEL are aluminum chloride containing astringent/ hemostatic solutions and gels that are intended to be supplied with gingival retraction cord or cotton pellets that are either pre-impregnated or for end-user impregnation by soaking the cords or cotton pellets in these solutions. The aluminum chloride impregnated retraction material is then packed into the sulcus to temporarily displace gingival tissue to expose the sub-gingival margins and control sulcular seepage and hemorrhage for impression taking and other restorative treatments. The supplied retraction material is available as an aqueous aluminum chloride solution or gel and either unit-dose 2"-pieces of braided cotton cord, braided cotton-polyester cord, or unit-dose cotton pellets.

5

Table 5.3: Design Description: Subject Device – Configuration, Component Sizes by Part Number, Exposure Time and Shelf Life

| Proposed
Device Name | Configuration | Part Number and Component Sizes | Time of Exposure
During
Treatment | Shelf Life and
Storage Conditions |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------|
| Styptin | Pre-Treated and Braided
Cotton Fiber Non-
Impregnated Retraction
Cord
and
Aqueous 20%
Aluminum Chloride
Solution | Retraction Cord:
Individual, 2-inch, pieces of retraction cord in
the following sizes*:
• Size On
• Size 1n
• Size 2n