AccessGUDID - DEVICE: PD MTA White (07640159160014)

GUDID

Device Identifier (DI) Information

Brand Name: PD MTA White
Version or Model: 20190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20190
Company Name: Produits dentaires S.A.

Primary DI Number: 07640159160014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480420090 *Terms of Use

Device Description: PD MTA White is a radiopaque root canal repair material material. The material composed of several mineral oxides is made up of thin hydrophilic particles showing the following advantages : – Optimized particle size allowing homogeneous and complete wetting during mixing – Avoids bacterial migration and penetration of tissue fluids into the root canal thanks to its excellent marginal sealing capacity – No need to dry the treated site. PD MTA White properties are not decreased in a moist environment The powder mixed with distilled water forms a gel, which cures in a humid environment. The material starts setting after approximately 10 minutes and the final setting time is 15 minutes. It is not necessary to wait for the final setting to continue the treatment procedure. Indications – Treatment of perforations of root canal and furcation – Treatment of internal resorption – Retrograde root canal filling after apical resection – Pulp capping – Pulpotomy – Apical plug during apexification treatment

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:	No
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?
36095	Endodontic filling/sealing material	A prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KIF	Resin, Root Canal Filling

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: Store at room temperature
Special Storage Condition, Specify: Protect from light
Special Storage Condition, Specify: Protect from humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 594861b6-54e9-41dc-8beb-de1fff552f93
Public Version Date: April 09, 2019
Public Version Number: 3
DI Record Publish Date: April 03, 2017