FDA UDI
In Commercial Distribution
🇺🇸 United States
K-ETCHANT Syringe
DI: EKUR003253KA1
·
Model: #3253-KA
·
KURARAY NORITAKE DENTAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- K-ETCHANT Syringe
- Primary DI
- EKUR003253KA1
- Version / Model
- #3253-KA
- Company Name
- KURARAY NORITAKE DENTAL INC.
- Labeler DUNS
- 697119498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2017-02-17
- Public Version
- 4
- Public Version Date
- 2021-08-10
- Public Version Status
- Update
- Public Device Record Key
- 8cd20d76-435a-49e9-a69a-e4cd1e61bc45
Device Description
Needle tips (E)
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
- 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 |
|---|---|---|---|---|
| 36153 | Dental etching solution | An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. 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 | EKUR003253KA1 | HIBCC | ||||
| Unit of Use | EKUR003253KA0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133078 | 000 |