GARRISON DENTAL SOLUTIONS, L.L.C.

Address:16673 148th Ave Unit 4,Spring Lake,MI,49456,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

Retainer, Matrix (JEP) (10)

Premarket Exempt

Yes No

Clear

Composi-Tight® - 30810038092646 Catalog Number : AU100

Device Description : Gold Matrix Band, Bicuspid

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 100

Composi-Tight® - 30810038092653 Catalog Number : AU300

Device Description : Gold Matrix Band with Extension, Molar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

Composi-Tight® - 30810038092660 Catalog Number : AU200

Device Description : Gold Matrix Band, Molar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 100

Composi-Tight® - 30810038092677 Catalog Number : AU050

Device Description : Gold Matrix Band with Extension, Pediatric

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

Composi-Tight® - 30810038092684 Catalog Number : AU150

Device Description : Gold Matrix Band with Extension, Bicuspid

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

Composi-Tight® - 30810038092745 Catalog Number : FX100

Device Description : 3D Fusion™ Full Curve Matrix Band with Extension, Bicuspid, Gray

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 100

Composi-Tight® - 30810038092752 Catalog Number : FX150

Device Description : 3D Fusion™ Full Curve Matrix Band with Extension, Bicuspid, Red

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 60

Composi-Tight® - 30810038092769 Catalog Number : FX175

Device Description : 3D Fusion™ Full Curve Matrix Band with Extension, Bicuspid, Purple

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 100

Composi-Tight® - 30810038092776 Catalog Number : FX200

Device Description : 3D Fusion™ Full Curve Matrix Band with Extension, Molar, Green

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 100

Composi-Tight® - 30810038092783 Catalog Number : FX300

Device Description : 3D Fusion™ Full Curve Matrix Band with Extension, Molar, Blue

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 60

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