FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Waterpik Kalginate Alginate Impression Material
DI: D6860150239
·
Model: 015023-000
·
WATER PIK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Waterpik Kalginate Alginate Impression Material
- Primary DI
- D6860150239
- Version / Model
- 015023-000
- Catalog Number
- 015023-000
- Company Name
- WATER PIK, INC.
- Labeler DUNS
- 001804074
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-02
- Public Version
- 5
- Public Version Date
- 2025-09-16
- Public Version Status
- Update
- Public Device Record Key
- a20e63cf-ca82-4159-a083-1cd5ccd9fb6c
- Distribution End Date
- 2025-09-15
Device Description
Fast Set
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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35863 | Alginate dental impression material | A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6860150239 | HIBCC |
Customer Contacts
- Phone
- (800) 525-2020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970594 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Pound |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius