YOUNG DENTAL MANUFACTURING I, LLC

Address:13705 Shoreline Ct E,EARTH CITY,MO,63045,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

CUP, PROPHYLAXIS (EHK) (5) Disinfectant, medical devices (LRJ) (3) Handpiece, air-powered, dental (EFB) (1) Handpiece, contra- and right-angle attachment, dental (EGS) (1)

Premarket Exempt

No Yes

Clear

Biotrol - 00302730000429 Catalog Number : 296041

Device Description : Birex SE III, Introductory Pack, 6 pk - 1 fl oz pkt (9346SE) - Disinfectant

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Biotrol - 00302730000436 Catalog Number : 296042

Device Description : Birex SE III, Operatory Pack, 12pk (12 x 1 fl oz) - Disinfectant

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Denticator - 00302730000504 Catalog Number : 530714

Device Description : Denticator Prophy Cup, Regular Firm, Regular Size White 4-Web Cup, Metal Latch Type

Device Class : 1

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : Yes

Device Count : 1

Young - 00302730000528 Catalog Number : 296304

Device Description : Young Vera DPA Splatter Guard Elite, Latex Free, Soft, Short, Web Purple Cup, Sample, 3ct

Device Class :

Duns Number: 006309355

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

Biotrol - 00302730001570 Catalog Number : PI016A

Device Description : Biotrol Purit Cide-it III, Ultrasonic Instrument Cleaner, 16oz

Device Class :

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Young - 00302730001686 Catalog Number : 295868

Device Description : Young Petite Web Prophy Cup, Latex Free, Soft, Short, Purple Web Cup, Latch Type

Device Class : 1

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : Yes

Device Count : 1

Young - 00302730001693 Catalog Number : 296619

Device Description : Young Prophy Cup, Latex Free, Soft, Long, Purple Web Cup, Latch Type

Device Class : 1

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : Yes

Device Count : 1

Young - 00302730001709 Catalog Number : 296620

Device Description : Young Elite Flex Prophy Cup, Latex Free, Extra Soft, Pink Cup, Latch Type

Device Class : 1

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : Yes

Device Count : 1

Young - 00302730001716 Catalog Number : 295867

Device Description : Young Elite Prophy Cup, Latex Free, Soft, Short, Purple Turbo Plus Cup, Latch Type

Device Class : 1

Duns Number: 006309355

Premarket Exempt : Yes

Product Code : EHK

Prescription Use : Yes

Device Count : 1

Athena Champion - 00302730001747 Catalog Number : AC5000-4P

Device Description : Athena Champion Standard Head Handpiece, Push Button Type, High Speed, 4 Hole Connector

Device Class : 1

Duns Number: 006309355

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

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