FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NuSmile NeoMTA
DI: 00862487000320
·
Model: NMTA 7.0
·
NUSMILE, LTD.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NuSmile NeoMTA
- Primary DI
- 00862487000320
- Version / Model
- NMTA 7.0
- Catalog Number
- None
- Company Name
- NUSMILE, LTD.
- Labeler DUNS
- 185497372
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-15
- Public Version
- 4
- Public Version Date
- 2021-06-25
- Public Version Status
- Update
- Public Device Record Key
- 70f44890-0249-4f24-bc2a-822c6769d4e1
- Distribution End Date
- 2019-07-11
Device Description
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
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
- Yes
- 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 |
|---|---|---|---|---|
| 16704 | Glass ionomer dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused. | No | Active |
| 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 | 00862487000320 | GS1 |
Customer Contacts
- Phone
- 832-540-5964
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140955 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 7.0 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Moisture will reduce the shelf life of the powder
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep bottles tightly closed
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not refrigerate
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature