AccessGUDID - DEVICE: Superdent® Eugenol U.S.P. (D6871410504FG2)

GUDID

Device Identifier (DI) Information

Brand Name: Superdent® Eugenol U.S.P.
Version or Model: 1410504FG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1410504FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6871410504FG2
Issuing Agency: HIBCC
Commercial Distribution End Date: January 09, 2019
Device Count: 12
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Superdent® Eugenol U.S.P. 4 oz.

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
Total Volume: 118 Milliliter
Device Size Text, specify: 12 Bottles (4 oz/118mL)

Device Record Status

Public Device Record Key: 2e9e3258-efcf-408e-ace1-bea157c1cf61
Public Version Date: September 30, 2022
Public Version Number: 3
DI Record Publish Date: September 21, 2016