FDA UDI
In Commercial Distribution
🇺🇸 United States
EsBond
DI: 08809262955415
·
Model: 101-0501
·
Spident Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- EsBond
- Primary DI
- 08809262955415
- Version / Model
- 101-0501
- Catalog Number
- 101-0501
- Company Name
- Spident Co., Ltd.
- Labeler DUNS
- 689370711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-20
- Public Version
- 9
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 200b3ebf-f00a-4479-a76b-270843aa3c04
Device Description
5th Generation Bonding. Light Cured, single bottle application bonding system.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 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 | 08809262955415 | GS1 | ||||
| Package | 20210305180053 | GS1 | 100 | Not in Commercial Distribution | 2019-05-16 | |
| Package | 00202202110062 | GS1 | 200 | Not in Commercial Distribution | 2021-01-25 | |
| Package | 00000202309208 | GS1 | 150 | Not in Commercial Distribution | 2023-09-20 |
Customer Contacts
- Phone
- 201-944-0511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120767 | 000 |