Dentsply De Trey GmbH

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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

MATERIAL, TOOTH SHADE, RESIN (EBF) (10)

Premarket Exempt

Yes

Clear

TPH Spectra ST - D0106422351 Catalog Number : 642235

Device Description : TPH Spectra ST Compules Refill HV A4 is a visible light cured, radiopaque, compo TPH Spectra ST Compules Refill HV A4 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422361 Catalog Number : 642236

Device Description : TPH Spectra ST Compules Refill HV BW is a visible light cured, radiopaque, compo TPH Spectra ST Compules Refill HV BW is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106424601 Catalog Number : 642460

Device Description : TPH Spectra ST Syringe Refill LV A1 is a visible light cured, radiopaque, compos TPH Spectra ST Syringe Refill LV A1 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

TPH Spectra ST - D0106424611 Catalog Number : 642461

Device Description : TPH Spectra ST Syringe Refill LV A2 is a visible light cured, radiopaque, compos TPH Spectra ST Syringe Refill LV A2 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

TPH Spectra ST - D0106424621 Catalog Number : 642462

Device Description : TPH Spectra ST Syringe Refill LV A3 is a visible light cured, radiopaque, compos TPH Spectra ST Syringe Refill LV A3 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

TPH Spectra ST - D0106424631 Catalog Number : 642463

Device Description : TPH Spectra ST Syringe Refill LV A3.5 is a visible light cured, radiopaque, comp TPH Spectra ST Syringe Refill LV A3.5 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

TPH Spectra ST - D0106424641 Catalog Number : 642464

Device Description : TPH Spectra ST Syringe Refill LV A4 is a visible light cured, radiopaque, compos TPH Spectra ST Syringe Refill LV A4 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

TPH Spectra ST - D0106424651 Catalog Number : 642465

Device Description : TPH Spectra ST Syringe Refill LV BW is a visible light cured, radiopaque, compos TPH Spectra ST Syringe Refill LV BW is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

TPH Spectra ST - D0106424701 Catalog Number : 642470

Device Description : TPH Spectra ST Syringe Refill HV A1 is a visible light cured, radiopaque, compos TPH Spectra ST Syringe Refill HV A1 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

TPH Spectra ST - D0106424711 Catalog Number : 642471

Device Description : TPH Spectra ST Syringe Refill HV A2 is a visible light cured, radiopaque, compos TPH Spectra ST Syringe Refill HV A2 is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth.

Device Class : 2

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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