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

Instrument, Diamond, Dental (DZP) (10)

Premarket Exempt

No Yes

Clear

FitStrip™ - 00810038094007 Catalog Number : FPSK01

Device Description : Starter Kit:(2) Serrated Strips, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.1 Starter Kit:(2) Serrated Strips, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm, (4) Double-Sided Strips - 1 of Each 0.11mm, 0.15mm, 0.21mm, 0.30mm, (2) Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094014 Catalog Number : FPSK02

Device Description : Single-Sided Kit:(2) Serrated Strips, (8) Single-Sided Strips - 2 of Each 0.08mm Single-Sided Kit:(2) Serrated Strips, (8) Single-Sided Strips - 2 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm, (2) Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094021 Catalog Number : FPSK03

Device Description : Double-Sided Kit:(2) Serrated Strips, (8) Double-Sided Strips - 2 of Each 0.11mm Double-Sided Kit:(2) Serrated Strips, (8) Double-Sided Strips - 2 of Each 0.11mm, 0.15mm, 0.21mm, 0.30mm, (2) Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094038 Catalog Number : FPSK04

Device Description : Universal Kit:(1) IPR Gauge, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.10mm, Universal Kit:(1) IPR Gauge, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm, (6) Double-Sided Strips - 1 of Each 0.11mm, 0.15mm, 0.21mm, 0.30mm, 0.40mm, 0.50mm, (2) Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094045 Catalog Number : FPSK05

Device Description : IPR Kit:(1) IPR Gauge, (10) Double-Sided Strips - 2 of Each 0.11mm, 0.21mm, 0.30 IPR Kit:(1) IPR Gauge, (10) Double-Sided Strips - 2 of Each 0.11mm, 0.21mm, 0.30mm, 0.40mm, 0.50mm, (2) Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094052 Catalog Number : FPSMDS

Device Description : Strip Refill, Double-Sided, Medium Grit, Blue: 10 Strips, 2 Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094069 Catalog Number : FPSMDS-1

Device Description : Double-Sided, Medium Grit, Blue

Device Class :

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094076 Catalog Number : FPSMSS

Device Description : Strip Refill, Single-Sided, Medium Grit, Blue: 10 Strips, 2 Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094083 Catalog Number : FPSMSS-1

Device Description : Single-Sided, Medium Grit, Blue

Device Class :

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

FitStrip™ - 00810038094090 Catalog Number : FPSSAW

Device Description : Strip Refill, Serrated, Gray: 10 Strips, 2 Handles

Device Class : 1

Duns Number: 057647005

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 1

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