AccessGUDID - DEVICE: Esthet-X® HD (D0026306061)

GUDID

Device Identifier (DI) Information

Brand Name: Esthet-X® HD
Version or Model: 630606
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 630606
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026306061
Issuing Agency: HIBCC
Commercial Distribution End Date: May 02, 2024
Device Count: 3
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Esthet-X® HD Compule Sampler - Shade A2

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:	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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, tooth shade, resin

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
Storage Environment Temperature: between 10 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep away from direct sunlight.
Special Storage Condition, Specify: Protect from moisture.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3 Compules® Tips - Shade A2

Device Record Status

Public Device Record Key: 7e021001-524b-42c3-ac4b-df46bd3cead8
Public Version Date: May 02, 2024
Public Version Number: 2
DI Record Publish Date: September 15, 2022