TPH Spectra ST - TPH Spectra ST Compules Refill LV A3.5 is a - Dentsply De Trey GmbH

Duns Number:315471722

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

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More Product Details

Catalog Number

642223

Brand Name

TPH Spectra ST

Version/Model Number

642223

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

0a34746c-fabb-4466-9a74-b1865bbd8381

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY DE TREY GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 36