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.

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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from the FDA for dental retraction materials (Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials). This type of document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and conducting studies to prove performance against those criteria in the way one might for a novel device or software.

Therefore, much of the requested information regarding detailed acceptance criteria and a specific study proving the device meets those criteria (especially clinical performance, AI/ML specific details like sample sizes for training/test sets, expert adjudication, or MRMC studies) is not applicable or not present in an FDA 510(k) summary for this type of device.

Here's a breakdown of what information can be extracted or inferred from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria, as in numerical thresholds for accuracy, sensitivity, or specificity commonly seen for diagnostics, are not presented for this device. Instead, the "acceptance criteria" are implied through demonstration of substantial equivalence to predicate devices, focusing on shared intended use, indications for use, fundamental technological characteristics, and safety profiles. Performance is primarily assessed through non-clinical testing and comparison of characteristics.

Acceptance Criteria Category (Derived from Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison and non-clinical tests)
Intended Use	Same as predicates: Temporary retraction of gingival margins and hemostasis procedures.
Indications for Use	Same as predicates: Temporary retraction of gingival margins and hemostasis for impression taking or other restorative procedures.
Target Users	Same as predicates: Licensed dental professionals.
Primary Mode of Action	Same as predicates: Mechanical displacement of gingival tissues.
Astringent/Hemostatic Agent	Aluminum Chloride (similar to reference predicates; primary predicate uses Aluminum Potassium Sulfate).
AlCl3 Content (weight/volume %)	GingiGel: 20%; Styptin: 20%; Hemogin-L: 25%; Hemodettes: 20% (Comparable to reference predicates Expa-syl (15%) and ViscoStat Clear (25%)).
Contact Time	< 5 minutes (comparable to predicates: < 5 minutes, 1-2 minutes, 1-3 minutes).
Shelf Life	GingiGEL, Styptin, Hemogin-L: 36 months; Hemodettes: 24 months (comparable to predicates ranging from 24 to 42 months).
Material Compatibility (Biocompatibility)	Meets requirements per ISO 10993 (same as predicates).
Physical Configuration	Variations (gel coated braid, aqueous solution, cotton pellets) are considered comparable to predicates (knitted/braided cord, paste, aqueous gel).
Non-Clinical Performance	Aluminum chloride content assessment, shelf life assessment, visual inspection, material composition analysis, cutting test, water contact test. Performed on "worst-case" product.
Biocompatibility Testing	Meets ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), and ISO 7405 (dental biocompatibility).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This is a non-clinical device involving dental retraction materials (cords, gels, solutions). The performance testing described is primarily non-clinical (material composition, physical properties, biocompatibility). Therefore, there isn't a "test set" in the sense of patient data. The non-clinical tests were performed on the device products themselves, and the sample sizes for those specific tests are not detailed in this summary document.
Data Provenance: Not applicable as it's primarily non-clinical testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not a diagnostic or AI/ML device that would require expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is not a diagnostic or AI/ML device that would require expert adjudication for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a manual dental tool/material, not an AI-assisted diagnostic. The document explicitly states: "Clinical performance testing has not been performed for the proposed device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the non-clinical tests conducted (e.g., biocompatibility, chemical analysis), the "ground truth" would be established by validated analytical methods and regulatory standards (e.g., ISO standards for biocompatibility), not expert consensus on patient cases or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device with a training set.

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

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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)

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 GingiGELAluminum 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+impregnatedAluminum PotassiumRetraction Cord	Expa-syl	ViscoStat Clear(Manufacturerrecommends using inconjunction with non-impregnated retractioncord.)
510(k) Sponsor	Sybron DentalSpecialties	Sybron DentalSpecialties	Ultradent Products Inc./ OraTech LLC
510(k) #	K162536(February 3, 2017)	K050180(February 11, 2005)	K123215(February 5, 2013)
RegulationNumber	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:

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

ProposedDevice Name	Configuration	Part Number and Component Sizes	Time of ExposureDuringTreatment	Shelf Life andStorage Conditions
Styptin	Pre-Treated and BraidedCotton Fiber Non-Impregnated RetractionCordandAqueous 20%Aluminum ChlorideSolution	Retraction Cord:Individual, 2-inch, pieces of retraction cord inthe following sizes*:• Size On• Size 1n• Size 2nAqueous AlCl3 Solution:• 13156: 15 mL• 13157: 30 mL	< 5 minutes	3 years at roomtemperature
Hemogin-L	Pre-Treated and BraidedCotton Fiber Non-Impregnated RetractionCordandAqueous 25%Aluminum ChlorideSolution	Retraction Cord:Individual, 2-inch, pieces of retraction cord inthe following sizes*:• Size On• Size 1n• Size 2nAqueous AlCl3 Solution:• 13057: 10 mL• 13058: 20 mL• 13052: 35 mL	< 5 minutes	3 years at roomtemperature
ProposedDevice Name	Configuration	Part Number and Component Sizes	Time of ExposureDuringTreatment	Shelf Life andStorage Conditions
Hemodettes	Pre-Treated and Pre-Soaked Cotton PelletsandAqueous, Buffered 20%Aluminum Chloride Gelin unit dose plastic cups	Retraction Cord (Cotton Pellets) and AqueousAlCl3 gel:2-Cotton Pellets and Buffered, Aqueous AlCl3Gel in Each Unit Dose, Plastic Cup:· 13150	< 5 minutes	2 years at roomtemperature
GingiGEL	Pre-Treated and BraidedPolyester and CottonFiber ImpregnatedRetraction CordwithAqueous 20%Aluminum Chloride Gel	Retraction Cord and Aqueous AICl3 Solution:· 13165:Size 1 (Small)· 13166:Size 2 (Medium)Pre-Treated and Impregnated Retraction Cord(6 feet in length) and Aqueous AICl3 Solutionare Stored in the Same Bottle.	< 5 minutes	3 years at roomtemperature

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*All 3 sizes are included in each finished good part number.

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E. Intended Use:

Retraction Cords are for the temporary retraction of the gingival margins and hemostasis procedures.

F. Indications for Use:

Aluminum Chloride impregnated retraction material 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.

Description of Safety and Substantial Equivalence: G.

Technological Characteristics

The subject Styptin, Hemogin-L, Hemodettes, and GingiGEL impregnated Aluminum Chloride Retraction Cords are substantially equivalent to the predicate devices (Table 5.2) cleared by the FDA for commercial distribution in the United States.

The aluminum chloride impregnated retraction material is placed directly into the sulcus with a dental instrument according to the dental clinician's preference. The aluminum chloride impregnated retraction cord is left in place less than 5 minutes for the proposed Styptin, Hemogin-L, GingiGEL, and Hemodettes. After treatment, the retraction cord/pellet is removed, and the treated area is rinsed with water with simultaneous aspiration. The area is gently air dried to obtain a dry retracted sulcus to continue additional dental restorative treatment.

All of the proposed and predicate devices are retraction materials that are placed into the sulcus to exert a gentle force onto the gingival tissue to physically displace and retract the gingival tissue away from the tooth. This mechanical mode of action directly results in temporarily exposing the sub-gingival margin to aid in taking impressions or other dental restorative treatments.

Astringent/Hemostatic Agent: Aluminum Chloride:

The proposed and predicate devices incorporate an astringent/ hemostatic agent containing aqueous aluminum chloride solution or gel. . Simply stated, aluminum chloride temporarily constricts blood vessels and extracts fluid from tissues. Aluminum chloride has been used for many years in this manner to help maintain the visual field of the exposed sub-gingival margins due to the physical displacement by the retraction cord. This action results in clear dental impressions and operative dental procedures requiring a well-defined dental margin and hemostasis and fluid control.

Configuration/Application Method Summary:

The proposed devices combine a few variations in application method due to the variations in configuration.

GingiGEL is an aluminum chloride impregnated, knit/twisted/ braided, cotton/ synthetic, retraction cords. These have been pre-impregnated prior to final packaging.
Styptin and Hemogin-L are examples of aqueous aluminum chloride solutions or ● gels used in conjunction with a non-impregnated cotton cord.

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. Hemodettes aqueous aluminum chloride solutions or gels used in conjunction with a non-impregnated cotton cord alterative, i.e. cotton pellets, coil, or caps.

Performance Testing

Non-Clinical Performance Data

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 subject device, Styptin, Hemogin-L, Hemodettes, and GingiGEL impregnated Aluminum Chloride Retraction Cord product line, directly contacts the patient for either less than 5 minutes.

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)

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Element	Proposed DevicesStyptin, Hemogin L,Hemodettes, andGingiGel	Primary PredicateGingiKnit+,GingiBraid+,GingiBraid+ Shortcut,and UniBraid+impregnatedAluminum PotassiumSulfate RetractionCord	Reference PredicateExpa-syl	Reference PredicateViscoStat Clear
510(k)	K162948	K162536	K050180	K123215
Trade/ProprietaryName	Styptin, Hemogin-L,Hemodettes, andGingiGEL AluminumChloride impregnatedRetraction Cords	GingiKnit+,GingiBraid+,GingiBraid+ Shortcut,and UniBraid+impregnatedAluminum PotassiumSulfate RetractionCord	Expa-syl	ViscoStat Clear(Manufacturerrecommends using inconjunction with non-impregnated retractioncord.)
Common Name	Retraction Material	Retraction Material	Retraction Material	Retraction Material
Product Code	MVL	MVL	MVL	MVL
Device Class	Unclassified	Unclassified	Unclassified	Unclassified
510(k) Sponsor	Sybron DentalSpecialties	Sybron DentalSpecialties	Sybron DentalSpecialties	Ultradent Products Inc./ OraTech LLC
Intended Use	Retraction Cords arefor the temporaryretraction of thegingival margins andhemostasis procedures.	Same	Same	Same
Indications forUse	Aluminum Chlorideimpregnated retractionmaterial are for the	GingiKnit+,GingiBraid+,GingiBraid+ Shortcut,	Expa-syl is a pastecontaining aluminumchloride which is	ViscoStat Clear isintended for sulcusretraction prior to
Element	Proposed DevicesStyptin, Hemogin L,Hemodettes, andGingiGel	Primary PredicateGingiKnit+,GingiBraid+,GingiBraid+ Shortcut,and UniBraid+impregnatedAluminum PotassiumSulfate RetractionCord	Reference PredicateExpa-syl	Reference PredicateViscoStat Clear
	temporary retraction ofthe gingival marginsand hemostasisprocedures. TheRetraction Cord isplaced in the sulcus todisplace the gingivaltissues for a shortperiod prior to makingan impression or forother restorativeprocedures.	and UniBraid+impregnatedAluminum PotassiumSulfate RetractionCords are for thetemporary retraction ofthe gingival marginsand hemostasisprocedures. TheRetraction Cord isplaced in the sulcus todisplace the gingivaltissues for a shortperiod prior to makingan impression or forother restorativeprocedures.	intended to be used forthe temporaryretraction andhemostasis of thegingival margin duringdental procedures suchas, but not limited to,dental impressions,seating of temporaryand permanentrestorations,restorations of cavitiesand placement of arubber dam	impression making andto control bleeding andgingival oozing inrestorative andoperative dentistryused with gingivalretraction cord and/orthe Dento-Infusor. Thegel facilitates theinsertion of the cordinto the sulcus.
Target Users	Licensed dentalprofessionals	Licensed dentalprofessionals	Licensed dentalprofessionals	Licensed dentalprofessionals
Primary Modeof Action	MechanicalDisplacementof gingival tissues fora short period prior totaking an impression	Same	Same	Same
Element	Proposed DevicesStyptin, Hemogin L,Hemodettes, andGingiGel	Primary PredicateGingiKnit+,GingiBraid+,GingiBraid+ Shortcut,and UniBraid+impregnatedAluminum PotassiumSulfate RetractionCord	Reference PredicateExpa-syl	Reference PredicateViscoStat Clear
	or other restorativeprocedures.
PhysicalConfiguration	Aluminum Chloridegel coated braid,Aqueous AluminumChloride solution,Cotton pelletssaturated in bufferedAluminum Chloridegel	Aluminum PotassiumSulfate ImpregnatedRetraction Cordavailable as Knitted,Braided, Braided withShortCut, and PreCutSingle Unit Dose	Paste	Aqueous gel
Astringent/HemostaticAgent	Aluminum Chloride	Aluminum PotassiumSulfate	Aluminum Chloride	Aluminum Chloride
AlCl3 Content(weight/ volume%)	1. GingiGel :20% AlCl32. Styptin :20% AlCl33. Hemogin-L :25% AlCl34. Hemodettes :20% AlCl3	None	15% AlCl3	25% AlCl3
Element	Proposed DevicesStyptin, Hemogin L,Hemodettes, andGingiGel	Primary PredicateGingiKnit+,GingiBraid+,GingiBraid+ Shortcut,and UniBraid+impregnatedAluminum PotassiumSulfate RetractionCord	Reference PredicateExpa-syl	Reference PredicateViscoStat Clear
Contact Time	1. GingiGEL, Styptin,Hemogin-L,Hemodettes:< 5 minutes	< 5 minutes	1-2 minutes	1-3 minutes
Shelf Life	1. GingiGEL:36 months2. Styptin:36 months3. Hemogin-L:36 months4. Hemodettes:24 months	36 months	24 months	42 months
MaterialCompatibility	Biocompatibilitymeets requirements perISO 10993	Biocompatibilitymeets requirements perISO 10993	Biocompatibilitymeets requirements perISO 10993	Biocompatibilitymeets requirements perISO 10993
PrimaryContainer	1. GingiGEL:Glass vial withsnap-top cap2. Styptin:Liquid:• 15mL - plasticsqueeze bottle• 30mL - amberglass bottle	Glass vial with snap-top cap and specializedShortCut system	Capsules	Plastic pre-filled,refillable, andIndiSpense refillsyringes
Element	Proposed DevicesStyptin, Hemogin L,Hemodettes, andGingiGel	Primary PredicateGingiKnit+,GingiBraid+,GingiBraid+ Shortcut,and UniBraid+impregnatedAluminum PotassiumSulfate RetractionCord	Reference PredicateExpa-syl	Reference PredicateViscoStat Clear
	3. Hemogin-L:Liquid:• Amber glassbottles with eyedropper lid4. Hemodettes:• Plastic unit dosecups with unique"finger ring"Cord in polybag

Table 5.4 Device Comparison Table Demonstrating Substantial Equivalence

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Clinical Performance Data

Clinical performance testing has not been performed for the proposed device.

H. Conclusion as to Substantial Equivalence:

Styptin, Hemogin L, Hemodettes, and GingiGel Aluminum Chloride impregnated retraction material is substantially equivalent to the primary predicate GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord (K162536). Both the subject device and the predicate device have the same intended use, indications for use, target users, primary mode of action, material compatibility, and primary packaging. The proposed devices and the primary predicate both meet their intended use through physical and mechanical means to displace or retract gingival tissue temporarily for impression taking or other restorative procedures. The subject device and the primary predicate have different hemostatic agents and are available in different configurations. configurations. The reference predicate Expa-syl (K050180) was selected as it has a similar design, the same intended use and hemostatic agent / astringest as the Styptin, Hemogin L, Hemodettes, and GingiGel proposed devices. Expa-syl has a slightly lower AICI3 content of 15% whereas the proposed subject devices contain a slightly higher amount of either 20% or 25%. Any noted differences in technological characteristics between the proposed and predicate devices do not raise new questions of substantial equivalence. Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride impregnated Retraction Material are substantially equivalent to the legally marketed predicate device Gingiknit+, Gingibraid+, Gingibraid+ Shortcut, and Unibraid+ Impregnated Aluminum Potassium Sulfate Retraction Cord (K162536), based on the design, performance, intended use, indications for use, and material compatibility.

Regulation Number and Section

N/A