FDA UDI
In Commercial Distribution
🇺🇸 United States
Smilegoods Sponge Dental Floss Mint Xylitol
DI: 00723896010174
·
Model: FL-1553
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
72
Basic Information
- Brand Name
- Smilegoods Sponge Dental Floss Mint Xylitol
- Primary DI
- 00723896010174
- Version / Model
- FL-1553
- Catalog Number
- 70-45200
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 72
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- b00d0bb3-1dff-4719-a18f-68bd7b626d48
Device Description
Innovative SmileGoods Sponge Dental Floss expands in contact with saliva to clean wider spaces more effectively. Contains beneficial xylitol for added defense against interproximal bacteria and plaque. Pocket-sized dispenser holds 12 yards of floss. 72 dispensers per case. Mint flavored.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JES | Floss, Dental | Dental | 872.6390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11158 | Dental floss | A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896010181 | GS1 | Case | 16 | In Commercial Distribution | |
| Primary | 00723896010174 | GS1 | ||||
| Unit of Use | 00723896004098 | GS1 |