AccessGUDID - DEVICE: Tenure® (D813032245101B0)

GUDID

Device Identifier (DI) Information

Brand Name: Tenure®
Version or Model: 032245101B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 032245101B
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: D813032245101B0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: TENURE S BND ENH 6mL R:1

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

GMDN Preferred Term Name

GMDN Definition

Dentine bonding agent/set

A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

FDA Product Code

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Product Code	Product Code Name
KLE	Agent, Tooth Bonding, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K801216	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Recommended temperature when used is 70° - 75° F (21° - 24° C)
Special Storage Condition, Specify: Do not expose to direct sunlight
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 36 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not freeze or refrigerate
Special Storage Condition, Specify: Do not expose to temperatures exceeding 80° F (27° C)

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75f3264c-6d7b-4a1a-b363-0d2e1fdef2d6
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016