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) (5) Pick, Massaging (JET) (5)

Premarket Exempt

No Yes

Clear

EQ-S - 08809455600580 Catalog Number :

Device Description : EQ-S TIP 25/02

Device Class : 1

Duns Number: 687503532

Premarket Exempt : Yes

Product Code : JET

Prescription Use : Yes

Device Count : 1

EQ-S - 08809455600597 Catalog Number :

Device Description : EQ-S TIP 35/02

Device Class : 1

Duns Number: 687503532

Premarket Exempt : Yes

Product Code : JET

Prescription Use : Yes

Device Count : 1

EQ-S - 08809455600603 Catalog Number :

Device Description : EQ-S (Gray) Full kit

Device Class : 1

Duns Number: 687503532

Premarket Exempt : Yes

Product Code : JET

Prescription Use : Yes

Device Count : 1

EQ-S - 08809455600610 Catalog Number :

Device Description : EQ-S (Pink) Full kit

Device Class : 1

Duns Number: 687503532

Premarket Exempt : Yes

Product Code : JET

Prescription Use : Yes

Device Count : 1

EQ-S - 08809455600627 Catalog Number :

Device Description : EQ-S PROTECTIVE SLEEVE

Device Class : 1

Duns Number: 687503532

Premarket Exempt : Yes

Product Code : JET

Prescription Use : Yes

Device Count : 1

i-ROOT 100 - 08809455600634 Catalog Number :

Device Description : i-ROOT 100

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT 100 - 08809455600641 Catalog Number :

Device Description : FILE HOLDER A FOR IROOT 100

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT 100 - 08809455600658 Catalog Number :

Device Description : FILE HOLDER B FOR IROOT 100

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT 100 - 08809455600665 Catalog Number :

Device Description : LIP HOLDER FOR IROOT 100

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

i-ROOT 100 - 08809455600672 Catalog Number :

Device Description : PROBE CORD FOR IROOT 100

Device Class : U

Duns Number: 687503532

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

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