GARRECO, LLC

Address:430 Hiram Road,Heber Springs,AR,72543,US

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Filters

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

Resin, Denture, Relining, Repairing, Rebasing (EBI) (7) Material, Impression Tray, Resin (EBH) (3)

Premarket Exempt

No Yes

Clear

Axcent Acrylics - D79338600080 Catalog Number : 3860008

Device Description : ACR MON #4 HI CLARITY SC (8 OZ EACH)

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79338600300 Catalog Number : 3860030

Device Description : ACR MON #4 HI CLARITY SC (QT EACH)

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79339100040 Catalog Number : 3910004

Device Description : ACR MON #5 POUR TYPE (4 OZ EACH)

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79339100080 Catalog Number : 3910008

Device Description : ACR MON #5 POUR LIQUID (8 OZ EACH)

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79339100300 Catalog Number : 3910030

Device Description : ACR MON #5 POUR TYPE 1 QT

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79339200040 Catalog Number : 3920004

Device Description : ACR MON #6 TRAY LIQUID (4 OZ EACH)

Device Class : 1

Duns Number: 364004762

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79339200080 Catalog Number : 3920008

Device Description : ACR MON #6 TRAY LIQUID (8 OZ EACH)

Device Class : 1

Duns Number: 364004762

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79339200300 Catalog Number : 3920030

Device Description : ACR MON #6 TRAY LIQUID 1 QT

Device Class : 1

Duns Number: 364004762

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79386010100 Catalog Number : 8601010

Device Description : Softliner Kit

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79386010200 Catalog Number : 8601020

Device Description : Softliner Refill Kit

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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