AccessGUDID - DEVICE: TPH®3 flow Liquid Micro Hybrid (D0026427161)

GUDID

Device Identifier (DI) Information

Brand Name: TPH®3 flow Liquid Micro Hybrid
Version or Model: 642716
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 642716
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026427161
Issuing Agency: HIBCC
Commercial Distribution End Date: November 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: TPH®3 flow Liquid Micro Hybrid Syringe Introductory 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:	No
Prescription Use (Rx):	No
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
EMA	CEMENT, DENTAL

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4 Syringes-1 of each shade: A1, A2, A3, A3.5 (1.3g each), 20 Unit Doses Prime & Bond NT Adhesive (0.125mL each), 1 Unit Dose Holder, 1 Syringe Tooth Conditioner Gel (3mL), Accessories
Weight: 1.3 Gram
Total Volume: 0.125 Milliliter

Device Record Status

Public Device Record Key: 63fa8c42-0431-4aa3-864c-7567b940685d
Public Version Date: October 03, 2022
Public Version Number: 3
DI Record Publish Date: September 23, 2016