FDA UDI
In Commercial Distribution
🇺🇸 United States
help:ex plaque p
DI: J009670000000
·
Model: 67000000
·
Renfert GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- help:ex plaque p
- Primary DI
- J009670000000
- Version / Model
- 67000000
- Catalog Number
- 67000000
- Company Name
- Renfert GmbH
- Labeler DUNS
- 328502976
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-10
- Public Version
- 1
- Public Version Date
- 2023-07-18
- Public Version Status
- New
- Public Device Record Key
- 7101cc92-ec7a-4c5f-ab93-0f9b2cbf9faa
Device Description
Cleanser for the removal of tartar and plaque on dental prostheses, Portioned with neutraliser, powder
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
- Yes
- 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 |
|---|---|---|---|---|
| NUX | Cleanser, Denture, Prescription | Dental | 872.3520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35871 | Denture cleanser | An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. 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 | J009670000000 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit