FDA UDI
In Commercial Distribution
🇺🇸 United States
GlasIonomer FX-LC
DI: 04548162343857
·
Model: C0063
·
SHOFU DENTAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- GlasIonomer FX-LC
- Primary DI
- 04548162343857
- Version / Model
- C0063
- Catalog Number
- C0063
- Company Name
- SHOFU DENTAL CORPORATION
- Labeler DUNS
- 054618202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-04-10
- Public Version
- 1
- Public Version Date
- 2026-04-20
- Public Version Status
- New
- Public Device Record Key
- 3c9ec342-b59a-4f2d-b143-2c6d4d3071a2
Device Description
GlasIonomer FX-LC CAPSULE LV B1 50pcs
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
- 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 |
|---|---|---|---|---|
| EMA | CEMENT, DENTAL | Dental | 872.3275 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 84548162343853 | GS1 | ||||
| Primary | 04548162343857 | GS1 |
Customer Contacts
- Phone
- +1(760) 736-3277
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252808 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 25 Degrees Celsius