FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Waterpik Opotow Trial Cement
DI: D686521203
·
Model: 052120-000
·
WATER PIK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Waterpik Opotow Trial Cement
- Primary DI
- D686521203
- Version / Model
- 052120-000
- Catalog Number
- 052120-000
- 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
- 5
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 63b4ae1b-a582-4dbc-840f-9f0f407d0e7a
- Distribution End Date
- 2023-12-05
Device Description
Non-hardening zinc oxide eugenol temporary dental cement
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 |
|---|---|---|---|---|
| 62200 | Zinc oxide eugenol dental cement | A non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components (e.g., rosin/colophony). 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 | D686521203 | HIBCC |
Customer Contacts
- Phone
- (800) 525-2020
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 10 | Gram | |
| Weight | 38 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit