A-DEC, INC.

A-DEC, INC.

Address:1601 Manufacturers Drive,Fenton,MO,63026,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

Evacuator, Oral Cavity (EHZ) (6) Unit, Operative Dental (EIA) (3) Unit, Syringe, Air And/Or Water (ECB) (1)

Premarket Exempt

No Yes

Clear

A-dec - 10194665000059 Catalog Number : 333

Device Description : A-dec 333 Continental Radius Delivery System

Device Class : 1

Duns Number: 009617473

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

A-dec - 10194665001391 Catalog Number :

Device Description : Vacuum CONN,W/HVE,5 FT

Device Class : 1

Duns Number: 009617473

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 1

A-dec - 10194665001414 Catalog Number : 11.0232.00

Device Description : Toothdryer ASSY-CE

Device Class : 1

Duns Number: 009617473

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

A-dec - 10194665001421 Catalog Number : 11.1009.00

Device Description : Dual HVE CVRSN Kit,Unitized HLDR,Cascade,4 POSN,Surf4

Device Class : 1

Duns Number: 009617473

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 1

A-dec - 10194665001476 Catalog Number : 11.1071.00

Device Description : Body,HVE,Autoclavable

Device Class : 1

Duns Number: 009617473

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 1

A-dec - 10194665001971 Catalog Number : 23.0872.00

Device Description : Syringe Tip,Laser Etch

Device Class :

Duns Number: 009617473

Premarket Exempt : No

Product Code : ECB

Prescription Use : No

Device Count : 1

A-dec - 10194665002961 Catalog Number :

Device Description : Tooth Dryer ASSY

Device Class : 1

Duns Number: 009617473

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

A-dec - 10194665004569 Catalog Number : 77.2094.00

Device Description : Vacuumm Tubings Kit,11MM + 15MM HVE,Autoclavable,Grey3,52 IN

Device Class : 1

Duns Number: 009617473

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 1

A-dec - 10194665004583 Catalog Number : 10.0015.00

Device Description : Tip,HVE,90 Degree,Square Ends,Passivated SST,OTC

Device Class : 1

Duns Number: 009617473

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 1

A-dec - 10194665005092 Catalog Number : 77.2083.00

Device Description : Kit,Vacuum Tubings ,11MM + 15MM HVE,Easyflex,Grey 3,63 IN

Device Class : 1

Duns Number: 009617473

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 1

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