DEVICE: International Dental Supply CuRay Match Visible Light Cure Composite Restorative (D801ID6602I1)
Device Identifier (DI) Information
International Dental Supply CuRay Match Visible Light Cure Composite Restorative
ID 66-02 I
In Commercial Distribution
66-02
SCIENTIFIC PHARMACEUTICALS, INC.
ID 66-02 I
In Commercial Distribution
66-02
SCIENTIFIC PHARMACEUTICALS, INC.
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Italian.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
42483 | Dentine adhesive |
A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K791132 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 23 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
334bfbb4-d726-431b-9083-a728b203b501
July 06, 2018
3
August 11, 2016
July 06, 2018
3
August 11, 2016
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
[?]
800-634-3047
Denise@scipharm.com 909-595-9922
Denise@scipharm.com
Denise@scipharm.com 909-595-9922
Denise@scipharm.com