ENDOCEM MTA PREMIXED REGULAR
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Basic Information
- Brand Name
- ENDOCEM MTA PREMIXED REGULAR
- Primary DI
- 08800071200291
- Version / Model
- ENDOCEM MTA PREMIXED REGULAR
- Company Name
- MARUCHI
- Labeler DUNS
- 557821685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-23
- Public Version
- 2
- Public Version Date
- 2024-03-19
- Public Version Status
- Update
- Public Device Record Key
- e86e8d37-5d4e-4e0b-b8df-4c573d27e927
Device Description
ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. It is designed to prevent irritation of pulp and secondary infections. ENDOCEM MTA PREMIXED REGULAR is a tricalcium-silicate based endodontic material as a premixed and preloaded syringe type. It conducts hydration reaction by absorbing the moisture around the root canal. The main compositions, directly relating to hydration reaction forming the hydrate gel, are calcium silicate and calcium aluminate. Bentonite Clay is added for hydrophilic properties inside the root canal so that it helps effective hydration reaction in the environment where there is a small amount of moisture. Other composition is relating to making ENDOCEM MTA PREMIXED REGULAR a premixed syringe type product for convenience usage.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 60510 | Hygroscopic dental cement | A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800071200291 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213757 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius