FDA UDI
In Commercial Distribution
🇺🇸 United States
Spot-On Etch
DI: 00348783000825
·
Model: 3001460
·
PREMIER DENTAL PRODUCTS COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spot-On Etch
- Primary DI
- 00348783000825
- Version / Model
- 3001460
- Company Name
- PREMIER DENTAL PRODUCTS COMPANY
- Labeler DUNS
- 014789663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2023-10-17
- Public Version Status
- Update
- Public Device Record Key
- 535cfd68-9468-4dac-9d5c-19a6a2f3bf6d
Device Description
Spot-On Etch Bulk 12 gram syringe, 50 tips
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 |
|---|---|---|---|---|
| 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 | 00348783000825 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141839 | 000 |