FDA UDI
In Commercial Distribution
🇺🇸 United States
INCISAL EDGE WEAR KIT
DI: E235IEWK0
·
Model: IEWK
·
SHOFU DENTAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INCISAL EDGE WEAR KIT
- Primary DI
- E235IEWK0
- Version / Model
- IEWK
- Catalog Number
- IEWK
- Company Name
- SHOFU DENTAL CORPORATION
- Labeler DUNS
- 054618202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-16
- Public Version
- 1
- Public Version Date
- 2024-10-24
- Public Version Status
- New
- Public Device Record Key
- 990c8439-9db7-4f8d-8a7b-5016c1669fe9
Device Description
IEWK (INCISAL EDGE WEAR KIT) Contains: Beautibond Bulk (E23517820), One Gloss PS IC (Bulk) In Pouch (E23501780). One Gloss PS Midi (bulk) (E23501770), Beautifil Flow Plus X F00 A3 (1 g sample) (similar to E235Y24030)
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set | A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not 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 | E235IEWK0 | HIBCC |
Customer Contacts
- Phone
- 760-736-3277
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082744 | 000 |