🚩 DEVICE: Waterpik Professional Dental Products Sample Pack (D686200327713)
Device Identifier (DI) Information
Waterpik Professional Dental Products Sample Pack
20032771-SAM
In Commercial Distribution
20032771-SAM
WATER PIK, INC.
20032771-SAM
In Commercial Distribution
20032771-SAM
WATER PIK, INC.
Pack includes: 4 Ultra Thin & Clear Varnish sticks, 4 Disposable Prophy Angles, 7 Prophy Paste cups, 1 Soft Shine Prophy Paste cup.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 35698 | Dental cavity varnish |
A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.
|
Active | false |
| 46938 | Dental polishing cup, single-use |
A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.
|
Active | false |
| 64015 | Dental-professional prophylaxis brush, single-use |
A non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.
|
Active | false |
| 11168 | Dentifrice |
A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LBH | Varnish, Cavity |
| EHK | Cup, Prophylaxis |
| EJR | Agent, Polishing, Abrasive, Oral Cavity |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Total Volume: 0.40 Milliliter |
| Weight: 2 Gram |
Device Record Status
ee21034d-c31a-4d4b-adcc-a739f67ebe61
September 01, 2023
1
August 24, 2023
September 01, 2023
1
August 24, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(800) 525-2020
professional@waterpik.com
professional@waterpik.com