ASEPTICO, INC.

Address:8333 216th St SE,WOODINVILLE,WA,98072,US

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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

Handpiece, Direct Drive, Ac-Powered (EKX) (9) Unit, Operative Dental (EIA) (4) Scaler, Ultrasonic (ELC) (3)

Premarket Exempt

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Aseptico - 10817417020012 Catalog Number : AEU-525S

Device Description : Transport III Portable electrical dental delivery system with built in Piezo ult Transport III Portable electrical dental delivery system with built in Piezo ultrasonic scaler

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : ELC, EKX, EIA

Prescription Use : Yes

Device Count : 1

Aseptico - 10817417020029 Catalog Number : AEU-525CF

Device Description : Transport III Portable electrical dental delivery system with built in Piezo ult Transport III Portable electrical dental delivery system with built in Piezo ultrasonic scaler and military spec case

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EIA, EKX, ELC

Prescription Use : Yes

Device Count : 1

Aseptico - 10817417020036 Catalog Number : AEU-525CFH

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EIA, EKX, ELC

Prescription Use : Yes

Device Count : 1

KERR - 10817417020043 Catalog Number : AEU-28KER

Device Description : HANDPIECE, DIRECT DRIVE, AC-POWERED (CONSOLE)

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

DENTSPLY Tulsa Dental Specialties - 10817417020074 Catalog Number : AEU-27T

Device Description : HANDPIECE, DIRECT DRIVE, AC-POWEREDEndodontic motor with rotary and reciprocatio HANDPIECE, DIRECT DRIVE, AC-POWEREDEndodontic motor with rotary and reciprocation drive, featuring a high torque brushless motor.

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

DENTSPLY Tulsa Dental Specialties - 10817417020081 Catalog Number : AE-250-30-T

Device Description : HANDPIECE, DIRECT DRIVE, AC-POWERED (MICROMOTOR)Accessory to AEU-27T.

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Aseptico - 10817417020104 Catalog Number : AMC-25

Device Description : Mobile Dental System

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

Aseptico - 10817417020739 Catalog Number : AEU-1000

Device Description : Dental Implant Motor System is a drive system for instruments and tools used in Dental Implant Motor System is a drive system for instruments and tools used in dentistry for implant procedures.

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Aseptico - 10817417020746 Catalog Number : AEU-1000-70V

Device Description : Dental Implant Motor System with Variable-Speed Footswitch. Drive system for ins Dental Implant Motor System with Variable-Speed Footswitch. Drive system for instruments and tools used in dentistry for implant procedures.

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

BlueSkiBio - 10817417020753 Catalog Number :

Device Description : The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch B The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch Blue Sky Bio is a drive system for instruments and tools used in dentistry for implant procedures.

Device Class : 1

Duns Number: 016853348

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

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