FDA UDI
In Commercial Distribution
🇺🇸 United States
Personalized SmileGoods PikPak Interproximal Cleaners
DI: 00723896011003
·
Model: 7109878P
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
72
Basic Information
- Brand Name
- Personalized SmileGoods PikPak Interproximal Cleaners
- Primary DI
- 00723896011003
- Version / Model
- 7109878P
- Catalog Number
- 71-09878P
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 72
- Record Status
- Published
- Publish Date
- 2018-07-19
- Public Version
- 2
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- b13a0e43-8540-4a24-b5dd-e5cc683b08be
Device Description
Put the power of a healthier smile in your patients’ pockets SmileGoods Personalized PikPak Interproximal Cleaners offer the same high quality at one-third the price of leading brands. The soft elastic bristles and flexible tapered handle are safe and effective for use on orthodontics, implants, and bridges. Business card-sized package slips easily into pocket, wallet, or purse, so patients can clean where their toothbrushes can’t go—on the go. Imprinted in black ink with up to four lines of 26 spaces each. 10 interproximal picks per pack,
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 |
|---|---|---|---|---|
| JET | Pick, Massaging | Dental | 872.6650 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33208 | Periodontal pick/brush, reusable | A manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00723896011003 | GS1 | ||||
| Unit of Use | 00723896008201 | GS1 |