PRIME DENTAL

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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

Material, Tooth Shade, Resin (EBF) (8) Crown, Preformed (ELZ) (1)

Premarket Exempt

No Yes

Clear

Prime-Dent Visible Light Cure Nano-Hybrid Composite - 00817441020005 Catalog Number :

Device Description : Visible Light Cure Nano-Hybrid Composite

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Prime Dent Visible Light Cure Nano Hybrid Composite Shade - 00817441020012 Catalog Number :

Device Description : Restorative Composite

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime Dent Visible Light Cure Nano Hybrid Composite - 00817441020029 Catalog Number :

Device Description : Restorative Composite

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime Dent Visible Light Cure Hybrid Composite Shade A3 - 00817441020326 Catalog Number :

Device Description : Prime Dent Visible Light Cure Hybrid Composite Shade A3

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime Dent Visible Light Cure Hybrid Composite Shade A2 - 00817441020524 Catalog Number :

Device Description : Prime Dent Visible Light Cure Hybrid Composite Shade A2

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime Dent Flowable Composite Shade A3.5 - 00817441020548 Catalog Number :

Device Description : Prime Dent Flowable Composite Shade A3.5 - 4.5g Syringe

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime Dent Flowable Composite Shade A1 - 00817441020722 Catalog Number :

Device Description : Prime Dent Flowable Composite Shade A1 - 4.5g Syringe

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime Dent Flowable Composite Shade A2 - 00817441020739 Catalog Number :

Device Description : Prime Dent Flowable Composite Shade A2- 4.5g Syringe

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime Dent Visible Light Cure Micro Hybrid Composite - 00817441020999 Catalog Number :

Device Description : Prime Dent Visible Light Cure Micro Hybrid Composite - 4 syringe KIT

Device Class :

Duns Number: 027480775

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Prime-Crown - 00817441022269 Catalog Number :

Device Description : temporary Crown material

Device Class : 1

Duns Number: 027480775

Premarket Exempt : Yes

Product Code : ELZ

Prescription Use : No

Device Count : 1

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