AccessGUDID - DEVICE: Zinc Oxide U.S.P. (D6870011804FG2)

GUDID

Device Identifier (DI) Information

Brand Name: Zinc Oxide U.S.P.
Version or Model: 0011804FG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0011804FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6870011804FG2
Issuing Agency: HIBCC
Commercial Distribution End Date: November 01, 2018
Device Count: 30
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Zinc Oxide U.S.P., Bottle, Powder 1lb

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):	No
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?
17610	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.	Active	false

FDA Product Code

[?]

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 Bottle (453.6 g)
Weight: 453.6 Gram

Device Record Status

Public Device Record Key: 30195551-1ab5-46f0-99bb-4d0c4da842bb
Public Version Date: September 23, 2022
Public Version Number: 3
DI Record Publish Date: September 21, 2016