FDA UDI
In Commercial Distribution
🇺🇸 United States
Refilit
DI: 00010705400883
·
Model: 1
·
MAJESTIC DRUG CO. INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Refilit
- Primary DI
- 00010705400883
- Version / Model
- 1
- Company Name
- MAJESTIC DRUG CO. INC.
- Labeler DUNS
- 001496777
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e320cdbc-6fb5-49e8-b4e5-98d4e6a2ce71
Device Description
Refilit is a Eugenol free temporary dental cement for replacing lost fillings
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMA | Cement, Dental | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62234 | Home-use dental cement | A non-sterile substance intended to be used as a dental cement/restorative material by a layperson in the home for immediate and temporary replacement of a lost filling or cementation of a dental crown, and to relieve pain, until a dental professional is accessed. It may be either a multicomponent material intended to be pre-mixed before application or a single-component paste; it is intended to be applied directly to the tooth and harden in situ. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30010705400884 | GS1 | Case | 16 | In Commercial Distribution | |
| Package | 70010705400882 | GS1 | Pack | 6 | In Commercial Distribution | |
| Primary | 00010705400883 | GS1 |
Customer Contacts
- Phone
- (800) 238-0220
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K964773 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature
- Type
- Special Storage Condition, Specify
- Special Conditions
- Closed Container