ORTHO SPECIALTIES

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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

Headgear, Extraoral, Orthodontic (DZB) (5) Material, Impression (ELW) (2)

Premarket Exempt

Clear

Flames Class III Adjustable Facemask - 00842452100637 Catalog Number : 600-527

Device Description : Adjustable Reverse Pull Headgear With Center Bar For Class III Treatment

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Leopard Print Class III Adjustable Facemask - 00842452100644 Catalog Number : 600-528

Device Description : Adjustable Reverse Pull Headgear With Center Bar For Class III Treatment

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Safety Release Modules Light - 00842452100651 Catalog Number : 600-557

Device Description : Safety Release Modules For Intraoral And Extraoral Headgear-16 Ounce Light

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Saftey Release Modules Medium - 00842452100668 Catalog Number : 600-558

Device Description : Safety Release Modules For Intraoral And Extraoral Headgear-20 Ounce Medium

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Safety Release Modules Heavy - 00842452100675 Catalog Number : 600-559

Device Description : Safety Release Modules For Intraoral And Extraoral Headgear-32 Ounce Heavy

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Allgilloid Plus™ Chromatic Cherry Alginate - 00842452100705 Catalog Number : 600-643C

Device Description : Chromatic (Color Changing) Impression Material For Dental Molds / Cherry Flavor

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

Allgilloid Plus™ Chromatic Mint Alginate - 00842452100712 Catalog Number : 600-643M

Device Description : Chromatic (Color Changing) Impression Material For Dental Molds / Mint Flavor

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : ELW

Prescription Use : Yes

Device Count : 1

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