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

FLOSS, DENTAL (JES) (7) Bracket, ceramic, orthodontic (NJM) (1) POST, ROOT CANAL (ELR) (1) RETRACTOR, ALL TYPES (EIG) (1)

Premarket Exempt

No Yes

Clear

Ultrapak - 00883205003751 Catalog Number : 137

Device Description : Ultrapak Cord #000

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : JES

Prescription Use : Yes

Device Count : 1

Ultrapak - 00883205003768 Catalog Number : 136

Device Description : Ultrapak Cord #00

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : JES

Prescription Use : Yes

Device Count : 1

Ultrapak - 00883205003782 Catalog Number : 134

Device Description : Ultrapak Cord #3

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : JES

Prescription Use : Yes

Device Count : 1

Ultrapak - 00883205003799 Catalog Number : 133

Device Description : Ultrapak Cord #2

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : JES

Prescription Use : Yes

Device Count : 1

Ultrapak - 00883205003805 Catalog Number : 132

Device Description : Ultrapak Cord #1

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : JES

Prescription Use : Yes

Device Count : 1

Ultrapak - 00883205003812 Catalog Number : 131

Device Description : Ultrapak Cord #0

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : JES

Prescription Use : Yes

Device Count : 1

Ultrapak - 00883205003829 Catalog Number : 130

Device Description : Ultrapak Cord Kit

Device Class : 1

Duns Number: 013369913

Premarket Exempt : No

Product Code : JES

Prescription Use : Yes

Device Count : 1

UniCore - 00883205003836 Catalog Number : 7125

Device Description : UniCore Post Size #1 Refill

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

Kleerview - 00883205003843 Catalog Number : 1821

Device Description : KleerView Adult Size

Device Class : 1

Duns Number: 013369913

Premarket Exempt : Yes

Product Code : EIG

Prescription Use : Yes

Device Count : 1

Luna - 00883205003874 Catalog Number : 221101

Device Description : Luna Opal MB Mini .022 UL1 (+17°T +4°A)

Device Class : 2

Duns Number: 013369913

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 1

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