YDM CORPORATION

Address:28 IMAIZUMI,,HIGASHIMATSUYAMA-SHI Saitama,JP

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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

Tray, Impression, Preformed (EHY) (2) Plier, Orthodontic (JEX) (1)

Premarket Exempt

Yes

Clear

NA - 04963931279340 Catalog Number : 27934

Device Description : The intended medical indication is to use to hold or to fix or to remove small o The intended medical indication is to use to hold or to fix or to remove small objects or to bend or to cut metal strips or wire or to cut out or make dents in several places on the resin orthodontic appliance.

Device Class : 1

Duns Number: 716059766

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

NA - 04963931279401 Catalog Number : 27940

Device Description : A horseshoe-shaped receptacle made of metal designed to carry dental impression A horseshoe-shaped receptacle made of metal designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression.

Device Class : 1

Duns Number: 716059766

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

NA - 04963931279418 Catalog Number : 27941

Device Class : 1

Duns Number: 716059766

Premarket Exempt : Yes

Product Code : EHY

Prescription Use : No

Device Count : 1

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