ULTRADENT PRODUCTS, INC.

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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

RETAINER, MATRIX (JEP) (6) BRACKET, METAL, ORTHODONTIC (EJF) (4)

Premarket Exempt

No Yes

Clear

Avex CX - 00883205108708 Catalog Number : 224016

Device Description : Avex CX .022 UR3 D/HK (-7°T 8°A)

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Avex CX - 00883205108715 Catalog Number : 224026

Device Description : Avex CX .022 UR4,5 D/HK (-7°T 0°A)

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Avex CX - 00883205108722 Catalog Number : 224018

Device Description : Avex CX .022 UU4,5 (-7°T 0°A)

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Avex CX - 00883205108739 Catalog Number : 214035

Device Description : Avex CX.018 LL4 (-12°T 2°A)

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Omni-Matrix - 00883205108753 Catalog Number : 1101

Device Description : Omni-Matrix Wingless 0.001 (Orange) Refill

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Omni-Matrix - 00883205108777 Catalog Number : 1103

Device Description : Omni-Matrix Wingless Mylar (Red) Refill

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Omni-Matrix - 00883205108784 Catalog Number : 1104

Device Description : Omni-Matrix Wingless Pedo (Purple)

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Omni-Matrix - 00883205108791 Catalog Number : 1105

Device Description : Omni-Matrix Wingless Kit

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Omni-Matrix - 00883205108807 Catalog Number : 2201

Device Description : Omni-Matrix Winged 0.001 (Orange) Refill

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

Omni-Matrix - 00883205108814 Catalog Number : 2202

Device Description : Omni-Matrix Winged 0.0015 (Green) Refill

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : JEP

Prescription Use : Yes

Device Count : 1

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