Duo:PCH® 032913130

GUDID D8130329131301

DUO PCH CTRL S 4pc #8&9 RFL

DEN-MAT HOLDINGS, LLC

Dental veneer, custom-made Dental veneer, custom-made Dental veneer, professional Dental veneer, professional Dental veneer, professional Dental veneer, professional Dental veneer, professional Dental veneer, professional Dental veneer, professional Dental veneer, professional Dental veneer, professional

Primary Device ID	D8130329131301
NIH Device Record Key	e25431ae-700e-4741-a885-75092bb2ad42
Commercial Distribution Status	In Commercial Distribution
Brand Name	Duo:PCH®
Version Model Number	032913130
Catalog Number	032913130
Company DUNS	809857704
Company Name	DEN-MAT HOLDINGS, LLC
Device Count	4
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze
Handling Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, Specify	Between 0 and 0 *Do not freeze

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130329131300 [Unit of Use]
HIBCC	D8130329131301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K895269

FDA Product Code

ELL	Teeth, Porcelain