Duo:PCH® 032913120

GUDID D8130329131201

DUO PCH CSPD M 4pc #6&11 RFL

DEN-MAT HOLDINGS, LLC

Dental veneer, custom-made
Primary Device IDD8130329131201
NIH Device Record Keyc9211ce5-6208-4f9c-ab0d-5d4b9e741987
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuo:PCH®
Version Model Number032913120
Catalog Number032913120
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8130329131200 [Unit of Use]
HIBCCD8130329131201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELLTeeth, Porcelain

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


[D8130329131201]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Duo:PCH®]

D8130396225101DUO PCH CEMENT MULTI-SHADE 4pk
D8130396224101DUO PCH CEMENT OM1 2pk
D8130396223101DUO PCH CEMENT A3.5 2pk
D8130396222101DUO PCH CEMENT A2/B2 2pk
D8130396221101DUO PCH CEMENT A1/B1 2pk
D8130329131801DUO PCH LTRL XS 4pc #7&10 RFL
D8130329131701DUO PCH CSPD XS 4pc #6&11 RFL
D8130329131601DUO PCH CTRL XS 4pc #8&9RFL
D8130329131501DUO PCH CSPD S 4pc #6&11 RFL
D8130329131401DUO PCH LTRL S 4pc #7&10 RFL
D8130329131301DUO PCH CTRL S 4pc #8&9 RFL
D8130329131201DUO PCH CSPD M 4pc #6&11 RFL
D8130329131101DUO PCH LTRL M 4pc #7&10 RFL
D8130329131001DUO PCH CTRL M 4pc #8&9 RFL
D8130329130901DUO PCH CSPD L 4pc #6&11 RFL
D8130329130801DUO PCH LTRL L 4pc #7&10 RFL
D8130329130701DUO PCH CTRL L 4pc #8&9 RFL
D8130329130601DUO PCH CSPD XL 4pc #6&11 RFL
D8130329130501DUO PCH LTRL XL 4pc #7&10 RFL
D8130329130401DUO PCH CTRL XL 4pc #8&9 RFL
D8130329130301DUO PCH CSPD S 4pc #22&27 RFL
D8130329130201DUO PCH LTRL S 4pc #23&26 RFL
D8130329130101DUO PCH CTRL S 4pc #24&25 RFL
D8130329129901DUO PCH CSPD M 4pc #22&27 RFL
D8130329129801DUO PCH LTRL M 4pc #23&26 RFL
D8130329129701DUO PCH CTRL M 4pc #24&25 RFL
D8130329127701DUO PCH LWR UNIV BS M RFL
D8130329127001DUO PCH LWR UNIV BS S RFL
D8130329126301DUO PCH UPR UNIV BS XL RFL
D8130329125601DUO PCH UPR UNIV BS L RFL
D8130329124901DUO PCH UPR UNIV BS M RFL
D8130329124201DUO PCH UPR UNIV BS S RFL
D8130329123501DUO PCH UPR UNIV BICS XS RFL
D8130329122001DUO PCH 28 UNIT STARTER KIT

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