PD MTA White
Basic Information
- Brand Name
- PD MTA White
- Primary DI
- 07640159160014
- Version / Model
- 20190
- Catalog Number
- 20190
- Company Name
- Produits dentaires S.A.
- Labeler DUNS
- 480420090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-03
- Public Version
- 3
- Public Version Date
- 2019-04-09
- Public Version Status
- Update
- Public Device Record Key
- 594861b6-54e9-41dc-8beb-de1fff552f93
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIF | Resin, Root Canal Filling | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640159160014 | GS1 |
Customer Contacts
- Phone
- +41219212631
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from light
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from humidity