Duns Number:119193803
Device Description: Put the power of a healthier smile in your patients’ pockets SmileGoods Personalized PikPa 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,
Catalog Number
71-09878P
Brand Name
Personalized SmileGoods PikPak Interproximal Cleaners
Version/Model Number
7109878P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JET
Product Code Name
Pick, Massaging
Public Device Record Key
b13a0e43-8540-4a24-b5dd-e5cc683b08be
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
July 19, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |