FDA UDI
In Commercial Distribution
🇺🇸 United States
Detail™ Pre-Impression Cleansing Gel
DI: 07540172000765
·
Model: 035904
·
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Detail™ Pre-Impression Cleansing Gel
- Primary DI
- 07540172000765
- Version / Model
- 035904
- Catalog Number
- 035904
- Company Name
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Labeler DUNS
- 626406016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-18
- Public Version
- 2
- Public Version Date
- 2022-11-01
- Public Version Status
- Update
- Public Device Record Key
- 71906a91-5c99-47b0-b7f0-5532a043e981
Device Description
Dental tooth-cleansing solution
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PME | external cleaning solution | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34524 | Dental tooth-cleaning solution | A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which 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 | 07540172000765 | GS1 | ||||
| Direct Marking | 07540172019163 | GS1 |
Customer Contacts
- Phone
- +1(800)265-3444
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius