← Product Code MVL · K162948 # Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (K162948) _Kerr Corporation · MVL · Aug 8, 2017 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K162948 ## Device Facts - **Applicant:** Kerr Corporation - **Product Code:** MVL - **Decision Date:** Aug 8, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use Retraction Cords are for the temporary retraction of the gingival margins and hemostasis procedures. ## Device Story Styptin, Hemogin-L, Hemodettes, and GingiGEL are dental retraction materials containing aluminum chloride astringent/hemostatic agents. The device consists of braided cotton or cotton-polyester cords, or cotton pellets, either pre-impregnated or for end-user impregnation with aqueous aluminum chloride solution or gel. Used by licensed dental professionals in a clinical setting, the material is packed into the gingival sulcus using a dental instrument. The cord exerts gentle mechanical force to displace gingival tissue, while the aluminum chloride constricts blood vessels and extracts fluid to control hemorrhage and seepage. The material remains in place for less than 5 minutes before removal, followed by rinsing and drying of the sulcus. This process exposes sub-gingival margins, facilitating clear dental impressions and restorative treatments. The device benefits patients by ensuring a dry, well-defined visual field for accurate dental procedures. ## Clinical Evidence No clinical data. Substantial equivalence is supported by non-clinical performance testing, including aluminum chloride content assessment, shelf life, visual inspection, material composition, cutting tests, water contact tests, and biocompatibility assessment per ISO 10993-1, ISO 10993-5, and ISO 7405. ## Technological Characteristics Materials: Braided cotton or cotton-polyester fibers. Astringent: Aqueous aluminum chloride solution or gel (20-25% concentration). Form factor: Unit-dose 2-inch cord pieces, cotton pellets, or bulk cord. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Biocompatibility: Compliant with ISO 10993 and ISO 7405. ## Predicate Devices - GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord ([K162536](/device/K162536.md)) - Expa-syl ([K050180](/device/K050180.md)) ## Reference Devices - ViscoStat Clear ([K123215](/device/K123215.md)) ## 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures intertwined to represent the relationship between health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white. 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 {2}------------------------------------------------ # 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)
| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo consists of the letters "sds" in a stylized, sans-serif font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, serif font. The logo is in a dark blue color. # 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 | {4}------------------------------------------------ #### 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

Aqueous AlCl3 Solution:
• 13156: 15 mL
• 13157: 30 mL | < 5 minutes | 3 years at room
temperature | | Hemogin-L | Pre-Treated and Braided
Cotton Fiber Non-
Impregnated Retraction
Cord
and
Aqueous 25%
Aluminum Chloride
Solution | Retraction Cord:
Individual, 2-inch, pieces of retraction cord in
the following sizes*:
• Size On
• Size 1n
• Size 2n

Aqueous AlCl3 Solution:
• 13057: 10 mL
• 13058: 20 mL
• 13052: 35 mL | < 5 minutes | 3 years at room
temperature | | Proposed
Device Name | Configuration | Part Number and Component Sizes | Time of Exposure
During
Treatment | Shelf Life and
Storage Conditions | | Hemodettes | Pre-Treated and Pre-
Soaked Cotton Pellets
and
Aqueous, Buffered 20%
Aluminum Chloride Gel
in unit dose plastic cups | Retraction Cord (Cotton Pellets) and Aqueous
AlCl3 gel:
2-Cotton Pellets and Buffered, Aqueous AlCl3
Gel in Each Unit Dose, Plastic Cup:
· 13150 | < 5 minutes | 2 years at room
temperature | | GingiGEL | Pre-Treated and Braided
Polyester and Cotton
Fiber Impregnated
Retraction Cord
with
Aqueous 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 Solution
are Stored in the Same Bottle. | < 5 minutes | 3 years at room
temperature | {6}------------------------------------------------ *All 3 sizes are included in each finished good part number. {7}------------------------------------------------ #### 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. {8}------------------------------------------------ - . 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) {9}------------------------------------------------ | Element | Proposed Devices
Styptin, Hemogin L,
Hemodettes, and
GingiGel | Primary Predicate
GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
and UniBraid+
impregnated
Aluminum Potassium
Sulfate Retraction
Cord | Reference Predicate
Expa-syl | Reference Predicate
ViscoStat Clear | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K162948 | K162536 | K050180 | K123215 | | Trade/
Proprietary
Name | Styptin, Hemogin-L,
Hemodettes, and
GingiGEL Aluminum
Chloride impregnated
Retraction Cords | GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
and UniBraid+
impregnated
Aluminum Potassium
Sulfate Retraction
Cord | Expa-syl | ViscoStat Clear
(Manufacturer
recommends using in
conjunction with non-
impregnated retraction
cord.) | | 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 Dental
Specialties | Sybron Dental
Specialties | Sybron Dental
Specialties | Ultradent Products Inc.
/ OraTech LLC | | Intended Use | Retraction Cords are
for the temporary
retraction of the
gingival margins and
hemostasis procedures. | Same | Same | Same | | Indications for
Use | Aluminum Chloride
impregnated retraction
material are for the | GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
| Expa-syl is a paste
containing aluminum
chloride which is | ViscoStat Clear is
intended for sulcus
retraction prior to | | Element | Proposed Devices
Styptin, Hemogin L,
Hemodettes, and
GingiGel | Primary Predicate
GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
and UniBraid+
impregnated
Aluminum Potassium
Sulfate Retraction
Cord | Reference Predicate
Expa-syl | Reference Predicate
ViscoStat Clear | | | 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. | and UniBraid+
impregnated
Aluminum Potassium
Sulfate Retraction
Cords 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. | intended to be used 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 | impression making and
to control bleeding and
gingival oozing in
restorative and
operative dentistry
used with gingival
retraction cord and/or
the Dento-Infusor. The
gel facilitates the
insertion of the cord
into the sulcus. | | Target Users | Licensed dental
professionals | Licensed dental
professionals | Licensed dental
professionals | Licensed dental
professionals | | Primary Mode
of Action | Mechanical
Displacement
of gingival tissues for
a short period prior to
taking an impression | Same | Same | Same | | Element | Proposed Devices
Styptin, Hemogin L,
Hemodettes, and
GingiGel | Primary Predicate
GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
and UniBraid+
impregnated
Aluminum Potassium
Sulfate Retraction
Cord | Reference Predicate
Expa-syl | Reference Predicate
ViscoStat Clear | | | or other restorative
procedures. | | | | | Physical
Configuration | Aluminum Chloride
gel coated braid,
Aqueous Aluminum
Chloride solution,
Cotton pellets
saturated in buffered
Aluminum Chloride
gel | Aluminum Potassium
Sulfate Impregnated
Retraction Cord
available as Knitted,
Braided, Braided with
ShortCut, and PreCut
Single Unit Dose | Paste | Aqueous gel | | Astringent/
Hemostatic
Agent | Aluminum Chloride | Aluminum Potassium
Sulfate | Aluminum Chloride | Aluminum Chloride | | AlCl3 Content
(weight/ volume
%) | 1. GingiGel :
20% AlCl3
2. Styptin :
20% AlCl3
3. Hemogin-L :
25% AlCl3
4. Hemodettes :
20% AlCl3 | None | 15% AlCl3 | 25% AlCl3 | | Element | Proposed Devices
Styptin, Hemogin L,
Hemodettes, and
GingiGel | Primary Predicate
GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
and UniBraid+
impregnated
Aluminum Potassium
Sulfate Retraction
Cord | Reference Predicate
Expa-syl | Reference Predicate
ViscoStat Clear | | Contact Time | 1. GingiGEL, Styptin,
Hemogin-L,
Hemodettes:
< 5 minutes | < 5 minutes | 1-2 minutes | 1-3 minutes | | Shelf Life | 1. GingiGEL:
36 months
2. Styptin:
36 months
3. Hemogin-L:
36 months
4. Hemodettes:
24 months | 36 months | 24 months | 42 months | | Material
Compatibility | Biocompatibility
meets requirements per
ISO 10993 | Biocompatibility
meets requirements per
ISO 10993 | Biocompatibility
meets requirements per
ISO 10993 | Biocompatibility
meets requirements per
ISO 10993 | | Primary
Container | 1. GingiGEL:
Glass vial with
snap-top cap
2. Styptin:
Liquid:
• 15mL - plastic
squeeze bottle
• 30mL - amber
glass bottle | Glass vial with snap-
top cap and specialized
ShortCut system | Capsules | Plastic pre-filled,
refillable, and
IndiSpense refill
syringes | | Element | Proposed Devices
Styptin, Hemogin L,
Hemodettes, and
GingiGel | Primary Predicate
GingiKnit+,
GingiBraid+,
GingiBraid+ Shortcut,
and UniBraid+
impregnated
Aluminum Potassium
Sulfate Retraction
Cord | Reference Predicate
Expa-syl | Reference Predicate
ViscoStat Clear | | | 3. Hemogin-L:
Liquid:
• Amber glass
bottles with eye
dropper lid
4. Hemodettes:
• Plastic unit dose
cups with unique
"finger ring"
Cord in polybag | | | | Table 5.4 Device Comparison Table Demonstrating Substantial Equivalence {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ ### 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. --- **Source:** [https://fda.innolitics.com/device/K162948](https://fda.innolitics.com/device/K162948) **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