DEVICE: Duo:PCH® (D8130329130601)
Device Identifier (DI) Information
Duo:PCH®
032913060
In Commercial Distribution
032913060
DEN-MAT HOLDINGS, LLC
032913060
In Commercial Distribution
032913060
DEN-MAT HOLDINGS, LLC
DUO PCH CSPD XL 4pc #6&11 RFL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
38645 | Dental veneer, professional |
A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELL | Teeth, Porcelain |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K895269 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not freeze |
Special Storage Condition, Specify: Do not expose to direct sunlight |
Storage Environment Temperature: between 33 and 75 Degrees Fahrenheit |
Handling Environment Temperature: between 33 and 75 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ac0887ef-d460-442c-850d-a4037eaccba2
February 05, 2021
4
September 24, 2016
February 05, 2021
4
September 24, 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:
D8130329130600
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-433-6628
info@denmat.com
info@denmat.com