FDA UDI
In Commercial Distribution
🇺🇸 United States
Patterson™ Super Concentrated Tartar and Stain Remover
DI: D687521368FG1
·
Model: 0521368FG
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Patterson™ Super Concentrated Tartar and Stain Remover
- Primary DI
- D687521368FG1
- Version / Model
- 0521368FG
- Catalog Number
- 0521368FG
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- a1bce165-90a4-4870-a4bd-5ecd51a58e6f
Device Description
Patterson™ Super Concentrated Ultrasonic Tartar and Stain Remover, 16 oz. Bottle
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EFT | CLEANSER, DENTURE, OVER THE COUNTER | 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 | D687521368FG1 | HIBCC | ||||
| Unit of Use | D687521368FG0 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 473 | Milliliter | |
| Device Size Text, specify | 6 Bettix Bottles (473ml) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store below freezing.