DERBY DENTAL LABORATORY, 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

Aligner, Sequential (NXC) (4) Maintainer, Space Preformed, Orthodontic (DYT) (3)

Premarket Exempt

No Yes

Clear

Smile Shapers, Tru-Smile - 00860002302300 Catalog Number :

Device Description : Discontinued - No longer in use.

Device Class : 2

Duns Number: 603741349

Premarket Exempt : No

Product Code : NXC

Prescription Use : No

Device Count : 1

Smile Shapers - 00860002302317 Catalog Number :

Device Description : Discontinued product code.

Device Class : 2

Duns Number: 603741349

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Smile Shapers - 00860002302324 Catalog Number :

Device Description : Discontinued product code.

Device Class : 1

Duns Number: 603741349

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : Yes

Device Count : 1

Tru-Smile - 00860002302331 Catalog Number :

Device Description : Clear sequential aligner (final retainer) / progressive orthodontic appliance system.

Device Class : 1

Duns Number: 603741349

Premarket Exempt : No

Product Code : DYT

Prescription Use : Yes

Device Count : 1

Tru-Smile - 00860002302348 Catalog Number :

Device Description : Clear sequential aligner / progressive orthodontic appliance system.

Device Class : 2

Duns Number: 603741349

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Phase Ortho - 00860002302355 Catalog Number :

Device Description : Discontinued product code.

Device Class : 2

Duns Number: 603741349

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Phase Ortho - 00860002302362 Catalog Number :

Device Description : Discontinued product code.

Device Class : 1

Duns Number: 603741349

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : Yes

Device Count : 1

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