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) (9) Forceps, Rubber Dam Clamp (EJG) (1)

Premarket Exempt

No Yes

Clear

Composi-Tight 3D Fusion - 00810038090221 Catalog Number : FX-HHF-50

Device Description : Composi-TIght 3D Fusion Firm Intro Kit

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Composi-TIght - 00810038090405 Catalog Number :

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Composi-Tight® - 00810038090429 Catalog Number :

Device Description : 3D Fusion™ Ring Placement Forceps

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : EJG

Prescription Use : Yes

Device Count : 1

Fusion - 00810038090436 Catalog Number : DME-01

Device Description : Deep Margin Elevation Kit

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Fusion - 00810038090443 Catalog Number : DME-02

Device Description : Deep Margin Elevation Kit

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Composi-Tight 3D Fusion Sectional Matrix System - 00810038090450 Catalog Number :

Device Description : 1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Fusion bands (20/5/20/20/5), 80 Fus 1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Fusion bands (20/5/20/20/5), 80 Fusion wedges (20 each), 1 FXP01, 4x Varistrips, 5x Margin Elevation bands

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Composi-Tight 3D Fusion Matrix System - 00810038090467 Catalog Number :

Device Description : 1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Firm bands (20ea FXH100, 5ea FXH150 1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Firm bands (20ea FXH100, 5ea FXH150, 20ea FXH175, 20ea FXH200, 5ea FXH300), 80 Fusion wedges (20 each), 1 FXP01, 4 Varistrips, 5 Margin Elevation bands

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Composi-Tight® - 00810038093673 Catalog Number : 3D400-1

Device Description : 3D Thin Tine G-Ring

Device Class :

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Composi-Tight® - 00810038093680 Catalog Number : 3D500-1

Device Description : Soft-Face™ 3D Ring

Device Class :

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Composi-Tight® - 00810038093697 Catalog Number : 3D600-1

Device Description : 3D Clear Soft Face™ Ring

Device Class :

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

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