DEVICE: OptiSonic™ super-concentrated general purpose ultrasonic cleaning solution (D6870321368FG2)

Download: XML | JSON

Device Identifier (DI) Information

OptiSonic™ super-concentrated general purpose ultrasonic cleaning solution
0321368FG
0321368FG
DENTSPLY INTERNATIONAL INC.
D6870321368FG2
HIBCC
6
OptiSonic™ super-concentrated tartar & stain remover ultrasonic cleaning solution, Six 16-oz Bettix Bottles
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Denture cleanser An agent used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with, e.g., a toothbrush. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EFT CLEANSER, DENTURE, OVER THE COUNTER
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 65 and 85 Degrees Fahrenheit
Special Storage Condition, Specify: Do not store below freezing.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Total Volume: 16 Fluid Ounce
Device Size Text, specify: Six 16-oz Bettix Bottles
CLOSE

Device Status

In Commercial Distribution
September 21, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D6870321368FG0 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
CLOSE