3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Address:16781 chagrin blvd,Shaker Heights,OH,44120,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

Wrap, Sterilization (FRG) (5) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

3D Dental - Kangaroo - 10817169021169 Catalog Number :

Device Description : Self-Seal Sterilization Pouches 200/Bx 2.25"x 4"- Case

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

3D Dental - Kangaroo - 10817169021183 Catalog Number :

Device Description : Self-Seal Sterilization Pouches 200/Bx 2.75" x 9" 10/Case

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

3D Dental - Kangaroo - 10817169021190 Catalog Number :

Device Description : Self-Seal Sterilization Pouches 200/Bx 3.5"x10" 10/Case

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

3D Dental - Kangaroo - 10817169021206 Catalog Number :

Device Description : Self-Seal Sterilization Pouches 200/Bx 5.25"x11" 10/Case

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

3D Dental - Kangaroo - 10817169021213 Catalog Number :

Device Description : Self-Seal Sterilization Pouches 100/Bx 7.5"x13"10/Case

Device Class : 2

Duns Number: 080194935

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

Comfortox - 10817169021954 Catalog Number :

Device Description : .5 CC 31 Gauge X 8 MM 3600

Device Class : 2

Duns Number: 080194935

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : No

Device Count : 1

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