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) (4)

Premarket Exempt

No Yes

Clear

Axcent Acrylics - D79386010300 Catalog Number : 8601030

Device Description : Softliner Application Kit

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79386010400 Catalog Number : 8601040

Device Description : Softliner Primer Kit

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79386010500 Catalog Number : 8601050

Device Description : Varnish BandC Kit

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Axcent Acrylics - D79386010600 Catalog Number : 8601060

Device Description : Softliner Gun

Device Class : 2

Duns Number: 364004762

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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