FDA UDI
In Commercial Distribution
🇺🇸 United States
Ezfil TL
DI: 08806387894339
·
Model: 9433
·
Meta Biomed Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ezfil TL
- Primary DI
- 08806387894339
- Version / Model
- 9433
- Company Name
- Meta Biomed Co., Ltd.
- Labeler DUNS
- 688322841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-15
- Public Version
- 1
- Public Version Date
- 2020-03-23
- Public Version Status
- New
- Public Device Record Key
- b96a1599-b4db-41ce-835d-73198a14d094
Device Description
Dental composite resin is a device intended to restore carious lesions or structural defects in teeth. Ezfil is indicated for Class 1, 2, 3, 4, 5 restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs. The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806387894339 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191991 | 000 |