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) (8) Handle, Instrument, Dental (EJB) (2)

Premarket Exempt

No Yes

Clear

NiTin™ - 20810038094216 Catalog Number : NTOR

Device Description : Wedge Refill, Medium, Orange

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : Yes

Device Count : 100

NiTin™ - 20810038094223 Catalog Number : NTGR

Device Description : Wedge Refill, Large, Green

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : Yes

Device Count : 100

NiTin Garrison® - 20810038094278 Catalog Number : NTG100

Device Description : Full Curve Matrix Band with Extension, Premolar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

NiTin Garrison® - 20810038094285 Catalog Number : NTG150

Device Description : Full Curve Matrix Band with Extension, Premolar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

NiTin Garrison® - 20810038094292 Catalog Number : NTG175

Device Description : Full Curve Matrix Band with Extension, Molar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

NiTin Garrison® - 20810038094308 Catalog Number : NTG200

Device Description : Full Curve Matrix Band with Extension, Tall Molar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

NiTin Garrison® - 20810038094315 Catalog Number : NTG300

Device Description : Full Curve Matrix Band with Extension, Tall Molar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 50

Composi-Tight® - 30810038092509 Catalog Number : M300-M

Device Description : Matrix Band with Extension, Molar

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 25

Composi-Tight® - 30810038092523 Catalog Number : M050-M

Device Description : Matrix Band with Extension, Pediatric

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 25

Composi-Tight® - 30810038092530 Catalog Number : M150-M

Device Description : Matrix Band with Extension, Bicuspid

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 25

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