AccessGUDID - DEVICE: Duo:PCH® (D8130329131001)

GUDID

Device Identifier (DI) Information

Brand Name: Duo:PCH®
Version or Model: 032913100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 032913100
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: D8130329131001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: DUO PCH CTRL M 4pc #8&9 RFL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam 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

Public Device Record Key: 66efb02b-9c78-43ec-a81a-6cef85c938a1
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: 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: D8130329131000 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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