AccessGUDID - DEVICE: DenteShield Sample Opaque with Fluoride (00858290006598)

GUDID

Device Identifier (DI) Information

Brand Name: DenteShield Sample Opaque with Fluoride
Version or Model: 685DSSAMP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ELEVATE ORAL CARE, LLC

Primary DI Number: 00858290006598
Issuing Agency: GS1
Commercial Distribution End Date: December 02, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 002863526 *Terms of Use

Device Description: DenteShield Sample Opaque with Fluoride

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:	Yes
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?
34771	Dental unfilled resin sealant/coating	A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	Sealant, Pit And Fissure, And Conditioner

FDA Premarket Submission

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

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8de7312-6ac3-4b4d-8598-97d9b172c12b
Public Version Date: December 03, 2024
Public Version Number: 2
DI Record Publish Date: June 11, 2020