ENDOCEM MTA
Basic Information
- Brand Name
- ENDOCEM MTA
- Primary DI
- 08800071200079
- Version / Model
- ENDOCEM MTA
- Company Name
- MARUCHI
- Labeler DUNS
- 557821685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-16
- Public Version
- 1
- Public Version Date
- 2023-05-24
- Public Version Status
- New
- Public Device Record Key
- 5e2110e2-f4e8-4445-9b04-d9ca362a3687
Device Description
1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to prevent irritation of pulp and secondary infections. It is a powder type. Use with saline or distilled water. The mixing ratio is 300 mg / 0.12 cc. 2. Principle of operation: ENDOCEM MTA is natural pure cement based endodontic material. product based on the science of pozzolan reactions. It has a fast setting time that allows for resin bonding to occur immediately after setting. It maintains its integrity in less than ideal clinical situations, including contamination with blood or saliva and presence of inflammation or infection. 3. Storage conditions: 1) The product shall be kept out of direct sunlight and stored at room temperature. It shall not be stored in a place with high temperature and humidity. 2) The remaining material shall be disposed of. 4. Shelf life: 3 years from manufacture date if storage conditions are followed.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 08800071200079 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112078 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius