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510(k) Data Aggregation
K Number
K211420Device Name
Stasis Gel
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2022-03-14
(311 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.
Device Description
Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
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K Number
K211419Device Name
Gingi-Aid Gel
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2022-01-10
(248 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.
Device Description
Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Gingi-Aid Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
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K Number
K213149Device Name
VOCO Retraction Paste
Manufacturer
Voco GmbH
Date Cleared
2021-12-09
(73 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g - analogue or digital impressions - cementation of temporary and permanent restorations - preparation of class II and V fillings
Device Description
Not Found
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K Number
K200764Device Name
STATSTIX
Manufacturer
Centrix Incorporated
Date Cleared
2020-10-15
(205 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.
Device Description
StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.
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K Number
K193389Device Name
Vista Clear
Manufacturer
Inter-Med / Vista Dental Products
Date Cleared
2020-03-04
(89 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vista Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista Clear facilitates the insertion of the cord into the sulcus.
Device Description
Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.
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K Number
K190220Device Name
Vista FS, Vista FS Liquid
Manufacturer
Inter-Med / Vista Dental Products
Date Cleared
2019-06-10
(125 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vista FS and Vista FS Liquid are intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista FS Liguid facilitate the insertion of the cord into the sulcus.
Device Description
Vista FS and Vista FS Liquid are medical devices used to facilitate sulcus retraction prior to taking a dental impressions of a tooth. This entails placement of the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject devices facilitate the insertion of the cord into the sulcus while also facilitating the creating of a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.
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K Number
K171577Device Name
Smartcord, Smartcord X
Manufacturer
EASTDENT Co., Ltd
Date Cleared
2018-05-03
(338 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.
Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.
Device Description
Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.
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K Number
K162662Device Name
GingiDent Gingival Retraction Paste
Manufacturer
PAC-DENT INTERNATIONAL, INC.
Date Cleared
2017-10-20
(389 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.
Device Description
GingiDent gingival retraction paste is an astringent formulated to provide gingival retraction and hemostasis. GingiDent gingival retraction paste contains Aluminum Chloride and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. This product is a blue-green paste developed exclusively for transient surgically invasive use in the oral cavity. The paste contains Aluminum Chloride in a water-based clay inert carrier.
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K Number
K162948Device Name
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
Manufacturer
KERR CORPORATION
Date Cleared
2017-08-08
(291 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
K162536Device Name
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
Manufacturer
KERR CORPORATION
Date Cleared
2017-02-03
(144 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Product Code :
MVL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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