FDA UDI
In Commercial Distribution
🇺🇸 United States
Prevue Refill Kit
DI: D7796040153
·
Model: 604015
·
COSMEDENT, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Prevue Refill Kit
- Primary DI
- D7796040153
- Version / Model
- 604015
- Catalog Number
- 604015
- Company Name
- COSMEDENT, INC.
- Labeler DUNS
- 113911689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- c327b714-3e75-40a1-b69e-bb64c87dc2a7
Device Description
Prevue Try-In Refill Kit includes 5 (2.5g) syringes of Prevue Try-In Gel, 2 Cosmedent brushes (#1 and #3),and Syringe Tips (20 pack-19 gauge).
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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45407 | Professional dental abrasive material | A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7796040153 | HIBCC |