AccessGUDID - DEVICE: Henry Schein® Eugenol, USP (D6871710504FG2)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein® Eugenol, USP
Version or Model: 1710504FG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1710504FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6871710504FG2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Henry Schein® Eugenol - 4 oz bottle

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

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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
Denture reliner, soft, professional	A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

GMDN Preferred Term Name

GMDN Definition

Denture reliner, soft, professional

A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

FDA Product Code

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Product Code	Product Code Name
EMB	ZINC OXIDE EUGENOL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not expose to temperatures above 95° F (35° C)

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 12 Bottles (4 oz each)
Total Volume: 4 Fluid Ounce

Device Record Status

Public Device Record Key: adf6bf1d-c215-420b-b002-c80d448e55b1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016