DEVICE: Nupro (D00390741L011)
Device Identifier (DI) Information
Nupro
90741L01
In Commercial Distribution
Dentsply Professional
90741L01
In Commercial Distribution
Dentsply Professional
NUPRO Freedom™ with SmartMode™ Technology Cordless Prophy System Basic Kit - Lavender - Contains: 1 Cordless Prophy System, 20 Nupro Freedom® Disposable Prophy Angles, 1 Disposa-Shield® Barrier Trial Pack (Polyethylene Barriers)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 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 |
| 33878 | Cable/lead/sensor/probe cover, non-sterile |
A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PEM | Dental barriers and sleeves |
| EKX | HANDPIECE, DIRECT DRIVE, AC-POWERED |
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 -20 and 50 Degrees Celsius |
| Special Storage Condition, Specify: Atmospheric limitations 50 to 106 kPa. |
| Storage Environment Humidity: between 45 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
a63117ca-90c4-4e6a-9e07-b583912d1a81
March 29, 2018
2
January 31, 2017
March 29, 2018
2
January 31, 2017
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
[?]
+1(800)989-8825
xx@xx.xx
xx@xx.xx