FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Waterpik Krex Z.O.E. Impression Corrective Paste
DI: D686151013
·
Model: 015101-000
·
WATER PIK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Waterpik Krex Z.O.E. Impression Corrective Paste
- Primary DI
- D686151013
- Version / Model
- 015101-000
- Catalog Number
- 015101-000
- Company Name
- WATER PIK, INC.
- Labeler DUNS
- 001804074
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 3
- Public Version Date
- 2025-09-16
- Public Version Status
- Update
- Public Device Record Key
- 887865fa-790f-4007-9452-1aa21312148b
- Distribution End Date
- 2025-09-15
Device Description
Zinc oxide eugenol impression corrective paste, Type II medium-bodied, economy size
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMB | Zinc Oxide Eugenol | Dental | 872.3275 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17844 | Dental articulation paste/solution | A substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. 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 | D686151013 | HIBCC |
Customer Contacts
- Phone
- (800) 525-2020
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 139 | Gram | |
| Weight | 116 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit