E.M.S. Electro Medical Systems S.A.

Address:RTE DE CHAMP-COLIN 2,NYON Vaud,CH

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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

Scaler, Ultrasonic (ELC) (5) Agent, Polishing, Abrasive, Oral Cavity (EJR) (2) Handpiece, Air-Powered, Dental (EFB) (2) Airbrush (KOJ) (1)

Premarket Exempt

No Yes

Clear

AIR-FLOW - 07613353206239 Catalog Number :

Device Description : PERIOFLOW Handpiece set

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

AIR-FLOW - 07613353206284 Catalog Number :

Device Description : AIRFLOW PLUS

Device Class : 1

Duns Number: 481233849

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

AIR-FLOW - 07613353207045 Catalog Number :

Device Description : AIR-FLOW Handpiece 120°

Device Class : 1

Duns Number: 481233849

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

AIR-FLOW - 07613353207397 Catalog Number :

Device Description : AIRFLOW MAX Introduction Kit

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

AIR-FLOW - 07613353207946 Catalog Number :

Device Description : PERIO-FLOW HandpieceGrey

Device Class : 1

Duns Number: 481233849

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

PIEZON - 07613353208141 Catalog Number :

Device Description : PIEZON 250

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

AIR-FLOW - 07613353208264 Catalog Number :

Device Description : AIRFLOW PLUS

Device Class : 1

Duns Number: 481233849

Premarket Exempt : No

Product Code : EJR

Prescription Use : Yes

Device Count : 1

AIR-FLOW - 07613353209179 Catalog Number :

Device Description : AIRFLOW One

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

AIR-FLOW-PIEZON - 07613353212636 Catalog Number :

Device Description : AIRFLOW Prophylaxis Master

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

PIEZON - 07613353213046 Catalog Number : FS-295#B/005

Device Description : Instrument PI starter kit

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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