META SYSTEMS CO., LTD.

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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

Locator, Root Apex (LQY) (6) Plugger, Root Canal, Endodontic (EKR) (1)

Premarket Exempt

No Yes

Clear

EQ-V - 08809455601020 Catalog Number :

Device Description : Pack tip (60/05L), 1ea [V3]

Device Class : 1

Duns Number: 687503532

Premarket Exempt : Yes

Product Code : EKR

Prescription Use : Yes

Device Count : 1

i-ROOT - 08809455601051 Catalog Number :

Device Description : Probe set

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT - 08809455601075 Catalog Number :

Device Description : File holder A

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT - 08809455601082 Catalog Number :

Device Description : File holder B

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT - 08809455601099 Catalog Number :

Device Description : Lip holder

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT - 08809455601105 Catalog Number :

Device Description : Probe cord

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

EQ-PEX - 08809455601167 Catalog Number :

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

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