AccessGUDID - DEVICE: TPH Spectra ST (D0106420151)

GUDID

Device Identifier (DI) Information

Brand Name: TPH Spectra ST
Version or Model: 642015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 642015
Company Name: Dentsply De Trey GmbH

Primary DI Number: D0106420151
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: TPH Spectra ST HV Risk Free Trial Kit is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth. The Compules Tips Gunr is used for the extrusion and direct application of the Compules Tips. With its supporting accessory (Compules Tips Gun) it can be classified as a convenience kit.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 28 Degrees Celsius
Special Storage Condition, Specify: Keep out of direct sunlight and protect from moisture

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.25 Gram
Device Size Text, specify: Paste

Device Record Status

Public Device Record Key: 432d172a-a51e-4074-99b8-7d03f933a701
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 14, 2017