FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Waterpik Ultra Thin & Clear Varnish
DI: D686200327623
·
Model: 20032762
·
WATER PIK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
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Basic Information
- Brand Name
- Waterpik Ultra Thin & Clear Varnish
- Primary DI
- D686200327623
- Version / Model
- 20032762
- Catalog Number
- 20032762
- Company Name
- WATER PIK, INC.
- Labeler DUNS
- 001804074
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2023-08-18
- Public Version
- 2
- Public Version Date
- 2025-09-16
- Public Version Status
- Update
- Public Device Record Key
- 85bc673a-b3e3-477a-b268-c15ba6321cde
- Distribution End Date
- 2025-09-15
Device Description
5% Sodium Fluoride, Melon flavor
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 |
|---|---|---|---|---|
| LBH | Varnish, Cavity | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35698 | Dental cavity varnish | A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D686200327620 | HIBCC | ||||
| Primary | D686200327623 | HIBCC |
Customer Contacts
- Phone
- (800) 525-2020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040098 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.40 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit