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 - D0106422201 Catalog Number : 642220

Device Description : TPH Spectra ST Compules Refill LV A1 is a visible light cured, radiopaque, compo TPH Spectra ST Compules 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 :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422211 Catalog Number : 642221

Device Description : TPH Spectra ST Compules Refill LV A2 is a visible light cured, radiopaque, compo TPH Spectra ST Compules Refill LV A2 is a visible light cured, radiopaque, composite restorative foranterior 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 - D0106422221 Catalog Number : 642222

Device Description : TPH Spectra ST Compules Refill LV A3 is a visible light cured, radiopaque, compo TPH Spectra ST Compules Refill LV A3 is a visible light cured, radiopaque, composite restorative foranterior 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 - D0106422231 Catalog Number : 642223

Device Description : TPH Spectra ST Compules Refill LV A3.5 is a visible light cured, radiopaque, com TPH Spectra ST Compules 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 :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422241 Catalog Number : 642224

Device Description : TPH Spectra ST Compules Refill LV A4 is a visible light cured, radiopaque, compo TPH Spectra ST Compules 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 :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422251 Catalog Number : 642225

Device Description : TPH Spectra ST Compules Refill LV BW is a visible light cured, radiopaque, compo TPH Spectra ST Compules 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 :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422311 Catalog Number : 642231

Device Description : TPH Spectra ST Compules Refill HV A1 is a visible light cured, radiopaque, compo TPH Spectra ST Compules 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 :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422321 Catalog Number : 642232

Device Description : TPH Spectra ST Compules Refill HV A2 is a visible light cured, radiopaque, compo TPH Spectra ST Compules 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 :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422331 Catalog Number : 642233

Device Description : TPH Spectra ST Compules Refill HV A3 is a visible light cured, radiopaque, compo TPH Spectra ST Compules Refill HV 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 :

Duns Number: 315471722

Premarket Exempt : Yes

Product Code : EBF

Prescription Use : Yes

Device Count : 20

TPH Spectra ST - D0106422341 Catalog Number : 642234

Device Description : TPH Spectra ST Compules Refill HV A3.5 is a visible light cured, radiopaque, com TPH Spectra ST Compules Refill HV A3.5 is a visible light cured, radiopaque, composite restorative foranterior 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

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