SCOTT'S DENTAL SUPPLY L.L.C.

Address:7217 45th St. Ct E,Fife,WA,98424,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Tooth Shade, Resin (EBF) (10)

Premarket Exempt

No Yes

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SCOTT'S SELECT FLOWABLE COMP 4-2gm (A4) - D77819950051 Catalog Number : 199-5005

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: A4. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (B2) - D77819950061 Catalog Number : 199-5006

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: B2. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (B3) - D77819950071 Catalog Number : 199-5007

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: B3.Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (C1) - D77819950081 Catalog Number : 199-5008

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: C1. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (C3) - D77819950091 Catalog Number : 199-5009

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: C3. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (OPAQ) - D77819950101 Catalog Number : 199-5010

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: OPAQUEInstructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (B1) - D77819950111 Catalog Number : 199-5011

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: B1. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (C2) - D77819950131 Catalog Number : 199-5013

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: C2. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (C4) - D77819950141 Catalog Number : 199-5014

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: C4. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

SCOTT'S SELECT FLOWABLE COMP 4-2gm (D3) - D77819950161 Catalog Number : 199-5016

Device Description : Scott's Select Flowable Composite is a 41% filled (by volume) composite based on Scott's Select Flowable Composite is a 41% filled (by volume) composite based on a resin system of BIS-GMA and triethylene glycol dimetacrylate. The filler has particle sizes ranging from sub-micron to 8 microns. Contains 2% Sodium Fluoride (by weight). There is about 1wt% catalysts, inhibitors and pigments.Shade/Color: D3. Instructions for use and SDS available at: https://www.scottsdental.com/flowable-composite-scott-s-select.html

Device Class :

Duns Number: 137217043

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 4

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