DEVICE: Duo:PCH® (D8130329130401)

Device Identifier (DI) Information

Duo:PCH®
032913040
In Commercial Distribution
032913040
DEN-MAT HOLDINGS, LLC
D8130329130401
HIBCC

4
809857704 *Terms of Use
DUO PCH CTRL XL 4pc #8&9 RFL
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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
Dental veneer, custom-made A custom-made facial restoration of ceramic or polymer-based material (resin) used in aesthetic dentistry to correct the facial surface of a tooth. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
ELL Teeth, Porcelain
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K895269 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

bdda0a1c-5857-4443-a225-e9176eb5ee5b
July 06, 2018
3
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D8130329130400 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-433-6628
info@denmat.com
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