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) (2) Material, Impression (ELW) (1)

Premarket Exempt

Yes No

Clear

Prime Dent Tray Adhesive Blue - 00817441023433 Catalog Number :

Device Description : Prime Dent Tray Adhesive Blue

Device Class : 2

Duns Number: 027480775

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : No

Device Count : 1

Scott's Select Temporary Cement NE Jars - 00817441023532 Catalog Number :

Device Description : Scott's Select Temporary Cement NE Jars

Device Class :

Duns Number: 027480775

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Scott's Select RC Cream 2-9gm Syringe - 00817441023549 Catalog Number :

Device Description : Scott's Select RC Cream 2-9gm Syringe

Device Class :

Duns Number: 027480775

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Prime-Core Chemical Cure Core Build Up - 00817441023556 Catalog Number :

Device Description : Prime Core Chemical Cure Core Build Up Kit 15g/15g WHITE

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

Prime-Core DC Automix Core Build Up Material - 00817441023563 Catalog Number :

Device Description : Prime-Core DC Automix Core Build Up Material - BLUE - 50g KIT

Device Class : 2

Duns Number: 027480775

Premarket Exempt : No

Product Code : EBF

Prescription Use : No

Device Count : 1

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